PIPELINE_65

Issue 65

The Journal of the Pharmaceutical Information & Pharmacovigilance Association

January 2022

RESPONDING TO THE MHRA’S REQUIREMENT FOR A UK PSMF PHARMA AND THE NHS – THE RELATIONSHIP THAT NEEDS TO TAKE THE NEXT STEP? IMPLEMENTING CONVERSATIONAL AI SOLUTIONS IN MEDICAL INFORMATION CONTINUING PROFESSIONAL DEVELOPMENT AND PIPA ACCREDITATION PHARMACOVIGILANCE THROUGH MERGERS AND ACQUISITIONS

£12.00 or Free for Members 9 771478 327005 65

CONTENTS 1

Letter From the Editors

By Pooja Shah

3

Responding to the MHRA’s requirement for a UK Pharmacovigilance System Master File (PSMF): Strategy, planning, execution, and delivery

By Vasavi Kalyani Garlapalli, John Verheul, and Amisha Sandhu

8

PIPA Pharmacovigilance System Master File Working Group

By Sarah Hall

10

PIPA PSMF Guidance Document Questionnaire Responses

14

Pharma and the NHS – the relationship that needs to take the next step?

19

Medical Device Regulations

25

Implementing Conversational AI Solutions in Medical Information

By Anne Turnbull

By Ka-Mei Au

By Shailini Blackwell

29

Management of Product Information

By Charlotte Mason

32

Looking After Your Sleep

By Lisa Artis

34

Pharmacovigilance Through Mergers and Acquisitions

By Tom Nichols

36

Smart Search and Modern Medical Information (MI) Deliver Value For Your Teams and the Wider Business

By Dr. Keith Tsui and Dr. Paul Riley

38

Continuing Professional Development and PIPA Accreditation

By Anne Turnbull

43

President’s Report

By Tom Nichols

Copyright for any article accepted for publication in PIPELINE is transferred to PIPA once the article is submitted. Copyright covers the exclusive rights to reproduce & distribute the article in any form (such as photocopies or electronic copies) and applies to the complete article and any part within. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form without written permission from PIPA. PIPA will, wherever possible, grant permission to authors to subsequently use their articles, or to others to take limited numbers of copies, provided permission is obtained from the editors in advance. PIPA members are permitted to print a copy of PIPELINE and / or save a single copy of the electronic file for their personal use.While all reasonable efforts are made to ensure the accuracy of the information presented in this journal, the editors do not accept any liability for loss arising from reliance on the information presented.The opinions expressed in the journal are not necessarily those of PIPA, its Committee or companies to which members belong - unless otherwise stated.

PIPELINE Editor: Pooja Shah Design and Print: Zebrahouse Design and Print Ltd

www.zebrahouseprint.co.uk

LETTER FROM THE EDITORS

By Pooja Shah

Welcome to the final edition of PIPELINE for 2021, the publication of which was delayed slightly. This means the new year has already begun and we hope it’s started well for you.

Before we get on to what 2022 has in store for PIPA, I just wanted to reflect on 2021. With COVID-19 - and the uncertainty it brought along with it - continuing to hang around, 2021 was another year where life felt on hold and isolating for many. However, the rollout of vaccines and gradual easing of restrictions meant that a degree of “normality” started to kick in for many of us, which we hope brought with it some long-awaited positivity.

interest in PV was fuelled further when a review by the MHRA found, from ongoing safety surveillance, that of the 20 million people who had received the Oxford– AstraZeneca vaccine in the UK up to 31 March 2021, 79 people had suffered rare blood clots – 19 of whom died. As a result, the Joint Committee on Vaccination and Immunisation (JCVI) advised that under-30s should be offered an alternative jab to the Oxford–AstraZeneca vaccine due to the evidence linking it to rare blood clots.

September saw the rollout of the booster vaccines and, in November, the Omicron variant emerged.

Not only did 2021 see the introduction of new vaccines and therapies for the prevention and treatment of COVID-19, we shouldn’t forget the huge amount of research that is continually ongoing in other areas to provide hope for many living with incurable or life-limiting conditions. For example, in March 2021, the National Institute for Health and Care Excellence (NICE) approved a gene therapy, Zolgensma, for the treatment of severe spinal muscular atrophy in babies. At £1.79m, the drug is reportedly one of the most expensive to ever be granted use by the NHS.

In other news, we saw the demise of Prince Philip, an unveiling of a statue of Princess Diana at Kensington Palace by her two sons, and a State of the UK Climate report, published by the Met Office, which concluded that 2020 was the third warmest, fifth wettest and eighth sunniest year on record. According to the authors of the report, this, and the trend since 1990, showed climate change is already happening in the UK. Continuing this theme, the UK hosted the 26th UN Climate Change Conference of the Parties (COP26) in Glasgow on 31 October – 13 November. In sport, England made it to

The importance and value of pharmacovigilance was also highlighted internationally when reports on the side effects of the COVID-19 vaccines where published. The

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the final of the UEFA Euro 2020 championship which was watched by 31 million people - making it the most watched programme since Princess Diana’s funeral in 1997. And let’s not forget the 2021 Olympics, where team GB walked away with an amazing 65 medals. Whilst we are on the topic of sport, our ex-PIPA committee member, Tazneem Anwar, has recently been featured in Strava’s campaign and blogs such as ‘Building Community Through Running’.

like to advertise your company on one of these databases, please contact us via pipa@pipaonline.org for further information.

Please remember, if there is anything you would like to see PIPA get involved with or do, please do get in touch via pipa@pipaonline.org.

Going back to this edition of PIPELINE, we are delighted to present a wide range of articles, including summaries of some our conference sessions including one on medical device regulations and another on the relationship between the NHS and Pharma. We also have an article on responding to the MHRA’s requirement for a UK Pharmacovigilance System Master File (PSMF) by Vasavi Kalyani, John Verheul and Amisha Sandhu from Novartis.

I’m sure many of us went through highs and lows in 2021, but we hope the year also gave you the opportunity for personal growth, for finding balance in all aspects of your life and gave you space to think and prioritise your time and efforts on what is important to you. We hope 2022 gives you time to continue with your personal development.

We also have an article by Dr Keith Tsui from MedWise AI on smart search and modern medical information (MI) – delivering value for your teams and the wider business, as well as an article on implementing conversational articificial intelligence in MI by Shai Blackwell.

We also hope 2022 provides the opportunity for career development and further training. Our Training Working Party have been working extremely hard over the last year to expand our courses for you and to suit all career paths.

This year, we have brought back some of our face-toface trainings as we know there is value in meeting one another and bouncing ideas and thoughts off your peers and colleagues.

We’ve listed only a few of the many topical articles that we have collated for this edition, and we hope you enjoy reading it as much as we have enjoyed putting it together.

As always, we welcome your feedback and encourage you to interact with us and the other PIPA members via our online platforms.

With that in mind, the annual PIPA conference will once again be a face-to-face event. We look forward to meeting with you all again on 28th – 29th September 2022! Booking for this not-to-be-missed event is now open on the PIPA website, along with details of the conference programme: https://pipaonline.org/ conference/conference-2022/.

On that note, we hope to ‘see’ you all at some point this year, and we hope you and your loved ones continue to stay safe and happy!

Until the next edition of PIPELINE which will be after Easter, we hope you all have a wonderful start to 2022.

PIPA have also developed a continuing professional development (CPD) portal on its website, which allows easing recording and tracking of your professional development, allowing you to move up the levels of PIPA membership as you develop your career in Medical Information and/or Pharmacovigilance. This is a great resource for your own personal development so I cannot encourage you enough to read the article inside on this and start collecting your points.

If you want to make a contribution to PIPELINE, please feel free to contact us at journaleditor@pipaonline.org.

As usual, throughout 2022, we will be continuing with our free PIPA forums and webinars and PIPELINE journals.

We have also developed a database of vendors and companies that offer PV and MI services on our website, as well as our existing contractors’ database. These databases list the type of services that the organisations provide, allowing you to easily find a match to your requirements – be it out of hours cover, audit consultancy, medical writing or a software solution etc. If you would

Pooja Shah PIPELINE Editor

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RESPONDING TO THE MHRA’S REQUIREMENT FOR A UK PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF): Strategy, planning, execution and delivery

By Vasavi Kalyani Garlapalli, John Verheul, and Amisha Sandhu

The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the marketing authorisation holder (MAH) for their authorised medicinal products. In fact, it was the European Medicines Agency (EMA), in July 2012, who first formalised the concept of the PSMF via the Good Vigilance Practice (GVP) Module II guideline. With the United Kingdom’s (UK) departure from the European Union (EU), the Medicines & Healthcare products Regulatory Agency (MHRA) mandated an independent UKPSMF for MAHs. This article focuses on measures taken to strategise, plan, implement and publish a new UK PSMF during the rapidly evolving regulatory situation following the withdrawal of the UK from the EU. and should represent the global availability of safety data for those products.

In 2020, Novartis initiated preparatory actions, having anticipated that the new requirements should be implemented by the end of the Brexit transition period (early 2021). Several potential UK PSMF models were considered as options to meet the evolving requirements:

(reference: II.B.4. Information to be contained in the pharmacovigilance system master file- Paragraphs 1 and 2 of Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority.

GVP Module II – Pharmacovigilance system master file (Rev 2))

1. An integrated EU and UK PSMF 2. Pharmacovigilance Sub-System File (PSSF)

At this stage, due to the precise clarification of the scope of the UK PSMF (required to reflect only the PV system for the UK nationally authorised products*) and the representation of the global availability of safety data for those products, models 1 and 2 were excluded.

3. Standalone PSMF In terms of PSMF requirements, it was apparent early on that the MHRA would follow a similar approach to the EMA. However, the exact scope was clear only after the publication of new guidance from the MHRA on 1 Jan 2021. The scope of the UK PSMF was to describe the pharmacovigilance system for UK nationally authorised products, and was required to include the details of the UK Qualified Person for Pharmacovigilance QPPV. The annexes must be specific to UK nationally authorised products, including those in respect of Northern Ireland,

*Novartis has no Northern Ireland (NI) only licenses.

Due to the limited execution period, the strategy was to implement the stand-alone UK PSMF in two stages, which also enabled us to dovetail with the company’s ongoing EU-PSMF review cycle. This approach also provided an opportunity to assess how we could develop a UK PSMF 3

that reflected the global availability of safety data, where applicable:

ii) Identification of a National Contact Person for Pharmacovigilance (NCPPV) details under the QPPV back-up section and,

Step 1:

iii) Details specific to the UK licensing authority.

Register UK PSMF and reflect the UK content within the EU PSMF.

For the annexes, the UK-specific information (productspecific listings) was included. This was the optimal solution in January 2021 considering the evolving regulatory situation.

Novartis operates a single pharmacovigilance system with one named QPPV for both the EU and the UK; as a consequence, the content of the core PSMF remained broadly consistent with the EU. Exceptions to this were:

Step 2: Separate the UK content from the EU PSMF, thereby creating a stand-alone UK PSMF. The production of a stand-alone UK PSMF took place as follows:

i) Addition of the UK PSMF registration code on the cover page,

UK Stand-alone PSMF planning and execution

Planning Phase 1 Impact Assessment on legislations

3 Gap Assessment on EU PSMF

Execution Phase

2 Comparison of relevant legislations

4 Templates for UK PSMF

The 4 key exercises that brought forth UK PSMF model(refer figure 2)

Figure 1: UK Stand-alone PSMF planning and execution phase

4

1

Identified the stakeholders

2

Built-in a communication plan

3

Developed a local procedure

4

Exception to the Global procedure

5

Onboarding and Training

6

Compilation of input and Review

7

Release of the UK PSMF

i) Planning Phase: Key activities were performed during this phase that helped Novartis to design a hybrid model (union of local and global content) for the UK PSMF: 1. Impact Assessment was conducted both at a local and global level on relevant legislation including The Human Medicines Regulations (HMR) Schedule 12A and Exceptions and modifications to the EU guidance (GVP Module II) on good pharmacovigilance practices that apply to UK MAHs and the MHRA. 2. Comparison between HMR schedule 12A vs Exceptions and Modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs, the licensing authority, and GVP module II. 3. Gap Assessment on the EU PSMF to assess the content that could be used for the UK PSMF. 4. Templates were created for the main body and annexes utilising the existing EU PSMF structure.

How does the model work?

Main Body: Soon after the release of the EU PSMF, the main body was divided into modules aligned with GVP II. These global modules were inserted into the main body of the UK PSMF as applicable, according to the model below.

The modules which required only local information were drafted by the UK affiliate. Where a module required both global and local content, the local team added local content to the global module.

PSMF CORE MODEL - EXCECUTED UK Local PSMF

EU-PSMF

Section 1: Local Content

Module 1:

Section 2: Local Content

Module 2:

Global module 2 (attachment)

Section 3: Local Content

Company’s EU PSMF

Module 3: Section 4: Global module 4 (as attachment)

Module 4:

Section 5: Local content

Module 5: Divided into modules

Section 6: Local Content

Module 6:

Section: Local Content

Module 7:

Global module 5 (attachment) Global module 6 (attachment) Global module 7 (attachment)

Section 8: Local plus Global Content* *Consolidated list added for the easy linking of annexes

Module 8:

• • •

Figure 2: Working model representation for the main body of the PSMF 5

Hybrid model with global and local content.

Local content worded in the body of the UK PSMF Where the PV system for UK and EU authorised products is the same, the EU PSMF modules are inserted into UK PSMF

Annexes: As the scope of the UK annexes must reflect the global availability of safety data for UK MAHs, similar to the EU PSMF requirements for EU MAHs, the majority of the annexes were taken directly from the EU PSMF. Some of the annexes were prepared using local content originating from the UK as indicated below.

Annex Category

Local Content

A-Annexes

✔

B-Annexes

✔

Global Content

Notes UK QPPV and NCPPV content

✔

• •

Local agreements listings were organised into UK and Non-UK. Listing of global vendors supporting PV activities was added.

C-Annexes

✔

Global studies and programmes listed without reference to EU/UK MAs (same approach as EU-PSMF)

D-Annexes

✔

No UK-specific databases exist within Novartis

E-Annexes

✔

✔

• •

Global listings cover the procedures for whole PV system.

Additional list of dedicated Standard Operating Procedures (SOPs) which were introduced to cover UK activities consequent to exit from the EU

F-Annexes

✔

✔

•

Global Key Performance Indicators (KPIs) were added with an extension to local only information (for example: submissions to MHRA) KPIs of local vendors that support the UK organisation were included Safety Label changes for UK nationally- authorised products

• • G-Annexes H-Annexes

✔ ✔

Audits and deviations are process-specific and the processes are applicable to one PV system. Hence, global listings were included.

Listings are product-specific, UK annexes introduced

Figure 3: UK PSMF Annex Model

ii) Execution Phase: A team was formed comprising local and global experts.

This project team played a crucial role in ensuring that the following milestones were met to implement the UK PSMF: • Identifying local contributors to collect the information • Setting up a clear communication plan • Developing a Standard Operating Procedure specific to the UK for QPPV/NCPPV and PSMF processes • Creating an exception from the global procedure to extend its scope in terms of global support to the UK PSMF • On-boarding the contributors on the new procedure and exceptions • Compiling, aligning, and reviewing inputs from the local and global contributors • Final release of the UK PSMF 6

Challenges & Mitigations Challenge Resource challenge Lack of awareness among the PSMF contributors Tight timelines

Mitigation • Global team extended their support to the UK and colloborated intensively providing expertise gained from compiling the EU PSMF • Securing dedicated UK resources • Directed meetings to local and global contributors clarifying the scope and timelines of EU and UK PSMF releases • Clear correspondence and explanation of the method adopted for compiling the UK PSMF • Created a detailed, time-based, project plan • Created templates based on the EU PSMF to help local contributors include the required data

Figure 4: Challenges and Mitigations

First MHRA inspection of the UK PSMF:

• Any alternative approaches to the existing model based on the EU PSMF to facilitate the interchange of modules between EU and UK PSMF (for example: writing the EU PSMF as modules)

The first version of the UK PSMF was released in the last week of April 2021 and in the first week of May, a notification of inspection was received from the MHRA Inspectorate. The first version of the PSMF went through the inspection and no relevant findings or observations were included in the Inspection Report.

References 1. Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority.

GVP Module II – Pharmacovigilance system master file (Rev 2)

Conclusions: The key factors that played an important role in the implementation of the UK PSMF in the rapidly evolving situation were:

2. HMR Schedule 12A (part 1)

• Strategic planning and early initiation of the project

Vasavi Kalyani Garlapalli

• Good collaboration between local and global teams

Manager, QPPV office Novartis

• Clear communication and prior alignment on the expected inputs required from all of the stakeholders • Early identification of the challenges and prompt mitigation of issues identified

John Verheul Lead Operations and Strategy, QPPV office Novartis

The company’s UK PSMF fulfils the overall requirements as per the UK regulation. However, there is room for continuous improvement based on the following factors: • Inclusion of any future MAs specific for Northern Ireland (if any) • Responding to feedback from future inspections and audits

Amisha Sandhu Patient Safety Group Manager Novartis

• Adapting content of the Annexes to reflect only information specific to UK MAs in the PSMF (where applicable) 7

PIPA PHARMACOVIGILANCE SYSTEM MASTER FILE WORKING GROUP

By Sarah Hall PSMF Working Group: Sarah Hall, Mipsol Limited (Chair) Valentina Mancini, Shionogi (Vice Chair) Margherita D’Antuono, Italfarmaco Dora Amene, TMC Pharma

John Barber, Plain Pharma Ilaria Grisoni, Jazz Pharmaceuticals Anne Lloyd, Ethypharm Vasavi Garlapalli, Novartis

With more countries and regions requiring a Pharmacovigilance System Master File (PSMF), and following a suggestion from delegates at the 4th European Pharmacovigilance Congress, PIPA set up a PSMF Working Group to develop guidance for the PIPA membership. This article provides a bit more detail about the Working Group as well as the results of the PIPA PSMF survey.

Introduction

there are not enough details about the French PV system in an MAH’s EU PSMF. In addition, there are countries elsewhere in the world where the maintenance of a PSMF, or similar document, is a voluntary obligation.

The European Union (EU) requirement for a Pharmacovigilance System Master File (PSMF) to be maintained by all Marketing Authorisation Holders (MAHs), and made available upon request, has been in place since July 2012. It replaced the Description of the Pharmacovigilance System (DDPS) that was submitted with each new licence application and the Summary of Pharmacovigilance System (SPS) that was requested at the time of a Pharmacovigilance (PV) inspection. The PSMF is used for PV System oversight by the Qualified Person for Pharmacovigilance (QPPV), a tool for audit and inspection planning, and allows Competent Authorities to assess an MAH’s PV System during Marketing Authorisation applications and post-authorisation.

With the more complex and ever changing PSMF landscape, companies are trying to determine how to meet global PSMF requirements whilst limiting the amount of duplication of effort. Following a suggestion from delegates at the fourth European Pharmacovigilance Congress, where a PIPA update was presented by Sarah Hall, the PIPA PSMF Working Group (PSMF WG) has been set up.

The members of the PSMF WG have been involved in PSMF development and maintenance since 2012, have experience of development of PSMFs in numerous regions/territories and one has recently been through a successful MHRA PV inspection with a UK PSMF. The intention is to develop PSMF guidance for the PIPA membership.

For almost ten years we have developed and maintained our EU PSMFs, sharing best practice and learning from inspection findings. More recently other countries and regions have implemented similar legislation including the requirement to have an Arab Region PSMF since 2015 (or Pharmacovigilance Sub System File (PSSF) for multinational companies) and a United Kingdom of Great Britain and Northern Ireland (UK) PSMF since 1st January 2021. There are also specifics relating to EU Member States such as the requirement by the Agence nationale de sécurité du médicament et des produits de santé (ANSM) for the inclusion of a French addendum if

We want to make sure the guidance is as helpful as possible so, in July 2021, we created a survey to ask you, the PIPA membership, what your experience of PSMFs is, what you would like to see in a PSMF guidance document and areas that you consider to be the greatest challenges.

We were pleased to receive 50 responses and would like to thank those of you who took the time to answer 8

our questions. Responses were generally in line with the thoughts of the PSMF WG so that was reassuring.

a template isn’t provided as part of the Guidelines on good pharmacovigilance practices (GVP)) is because PV Systems are so different and a template would be too restrictive. Having said that, we will include example tables and other guidance to try to help address this request as much as we consider appropriate.

Survey responses We will consider all the responses when developing the guidance, but here is a headline summary.

Conclusion

47 of the 50 respondents are involved in development or maintenance of their company’s PSMF.

As mentioned previously, the members of the PSMF WG have a wealth of PSMF experience between them.

However, the landscape continues to change and we are still learning about the ‘new’ PSMFs such as the UK PSMF. For this reason, the guidance will be a ‘live’ document with updates as the MHRA releases details of UK PSMF inspection findings and guidance is released by other Competent Authorities.

In terms of content of the guidance document, 17 people would like clarity on development of the UK PSMF and how to address UK and EU PSMF requirements due to the Northern Ireland Protocol, 9 would like guidance on areas of the PSMF that are identical for all territories versus the information that needs to be specific for a given country or region and 23 requested more general PSMF guidance such as annex management and practical tips and advice on PSMF development and maintenance.

We are hoping to release the first version of the Guidance Notes in early 2022. We’re also considering PSMF workshops or a training course to complement the current PSMF face to face training course. So watch this space and if you have any comments or suggestions, please contact the PSMF WG via pipa@pipaonline.org

The ‘great unanswered questions’ included what the appropriate level of detail should be, what should go in the body versus annexes and how frequently the PSMF should be updated. 15 respondents considered the greatest challenge to be getting input from other functions and collecting data from multiple stakeholders.

The number of PSMFs being managed by respondent companies ranged from one to more than ten with PSMFs mainly for EU and UK, but also covering Switzerland, Arab States, Ghana, Nigeria, Malaysia and Latin America. Of those companies that have PSMFs covering the UK and EU, almost half had a joint EU/UK PSMF.

Sarah Hall Director MIPSOL Limited

Several respondents asked for a PSMF template.

However, we won’t be developing a PSMF template as part of the guidance. The reason for this (and why 9

PIPA PSMF GUIDANCE DOCUMENT QUESTIONNAIRE RESPONSES Question 1

Are you involved in development and / or maintenance of your company's PSMF? Answered: 50 • Skipped: 0

YES

NO

Total Answers

50 94%

Question 2

Post Brexit Challenges

6%

What would you like to see in a PIPA PSMF guidance document?

Answered: 49 • Skipped: 1 17 Answers were relevant to post-Brexit PSMF related aspects (e.g, how to manage a PSMF to fulfill UK and NI specific legal requirements; UK specific guidance; how to link UK and EU PSMF; guidance on overlaps and differences). Detailed answers as follows:

• How to produce a UK PSMF and How to link UK and EU PSMFs • How different types of MA appear in EU or UK PSMF • How to manage a core PSMF to fulfill UK and NI specific requirements and legal requirements in different regions • How to represent the required information and what each section should contain to fulfill UK and NI specific requirements and legal requirements in different regions • How to create UK specific annexes • Template of a typical PSMF and all of the annexes • Guidance for NI Protocol

Local vs Global

9 answers were relevant to the management of core PSMF vs different local requirements (Global vs Local). For example: How to write a Corporate PSMF that could align with the local regulatory requirements; a summary of differences in requirements for the different regions; summary of relevant legislation/guidance documents; how to manage Annexes; list of all applicable requirements 10

PIPA PSMF GUIDANCE DOCUMENT QUESTIONNAIRE

PSMF Management General Aspects

23 answers were relevant to general PSMF management aspects (what is the appropriate level of detail?; how often to should the PSMF be updated?; what is the content of the body vs annex, example templates and tips).

In addition, the following answers were received: • What should be included in the logbook?

• Which deviations/CAPAs to include (all that are relevant to PV or just the critical ones) • Which non-PV SOPs to include • How to manage KPIs • Should you record DSUR submission metrics in KPI Annex?

• Should you include processes relating to DSUR as outputs may affect risk management?

• Information on how to list different medicinal products with the same active ingredient • How to ensure content, particularly of annexes, remains accurate and up to date • How to manage multiple versions • Practical tips and advice on PSMF creation and maintenance

Question 3 PSMF General Aspects Management

Global vs Local

What do you consider to be the 'great unanswered questions' about the PSMF? Answered: 44 • Skipped: 6 • • • • • • • •

6 answers were relevant to the appropriate level of detail to be provided in PSMF 2 answers were relevant to what goes in annexes versus what goes in the body 5 answers were relevant to the update frequency 2 answer were relevant to the need to sign and who should sign it 3 were relevant to the need of a template 2 were relevant to possible use of technology 2 were relevant to management of cover page 3 on how to decide if one PSMF is enough and how to make it acceptable for all the Agencies • 2 on thresholds to include contractual agreements • 2 on which vendor to be included • 2 were relevant to inspection findings • 11 were relevant to management UK specificities (e.g. which content to include in UK PSMF vs EU PSMF), how to streamline processes and how to avoid duplication of effort • 9 were relevant to management of multiple local versions (e.g.Saudi) and how to streamline processes

Details of above mentioned answers: • How to adapt processes for EU PSMF versus UK PSMF to streamline process and reduce duplicate work • Managing multiple versions e.g. UK, EU Saudi etc • Global PSMF covering all countries who are affiliates, how do you go about creating a local PSMF without risking duplication 11

PIPA PSMF GUIDANCE DOCUMENT QUESTIONNAIRE Question 4

What do you consider to be the greatest challenges developing a PSMF? Answered: 46 • Skipped: 4

15 Answers were relevant to the difficulty to collaborate with different functions or with global functions and difficulties in collecting data from multiple stakeholders (other functions or from global PV) Some details of answers: • Accommodating multiple country requirements • Vendor listings (clear guidance on which kind of vendors the PSMF should list) • Collecting information from multiple stakeholders (multiple departments, partner organisations and vendors as well as non-GxP departments) • Mainteinance of annexes • Identifying what needs to be included and how much detail • Maintenance of both an EU and a UK PSMF • Increasing awareness of the importance of the PSMF • Lack of templates • Understanding the scope of the MAH's PV system • How to decide the "cut off point" between finalising different versions of the PSMF • The time taken to prepare the PSMF when PV resource is limited and other routine activities are completed as well • Ensuring that it contains accurate and all required information • Interpreting the regulations. Some parts are vague and our interpretation can be different from an inspectors • How to present your data so it is easy to follow the flow of information throughout the document • Setting up and maintaining KPIs for Global scope

Question 5 • • • • • • •

How many different PSMFs does your company have?

Answered: 47 • Skipped: 3

10 responders answered “1” 16 responders answered “2” (1 added “(EU and UK) and 1 local (France)” and another one added “EU and UK”) 4 responders answered “3” 5 responders answered “4” 1 responders answered “5” 1 responder answered “6” 1 responder answered 10+

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PIPA PSMF GUIDANCE DOCUMENT QUESTIONNAIRE Question 6

Which countries / regions do your company's PSMFs cover?

Answered: 48 • Skipped: 2

• 17 responders answered “EU and UK” • 4 responders answered “UK only” • 2 responders answered “EU”

Countries covered included: EU, UK, India, Middle East regions, Brazil, Switzerland, Eurasian region, Arab region

Question 7

Does your company have a PSMF that covers UK products?

Answered: 50 • Skipped: 0

Yes

No

9 (18%) 3 (6%)

If yes, is it separate from your company's EU PSMF?

38 (76%) • 18 responders answered “yes” • 11 responders answered “no” • 9 had hybrid models with the same PSMF body and EU and UK specific cover letters and/ annexes

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CONFERENCE 2021 PRESENTATION SUMMARIES Pharma and the NHS – the relationship that needs to take the next step?

By Anne Turnbull

In this workshop, PIPA Committee member and MI manager at Grunenthal, Harpreet Sandhu was joined by a panel of speakers to explore how Medical Information, as the non-promotional face of the Pharmaceutical Industry, can build on its relationship with the NHS, and wider initiatives, to educate healthcare professionals and promote the safe and effective use of medicines.

Health Education England National Pharmacy Programme

education and training. This includes allowing pharmacists to independently prescribe from registration.

They have also introduced a foundation training year – traditionally the pre-registration year - (Year 5) with strengthened supervision and support and collaborative working between higher education institutions, statutory education bodies (such as HEE) and employers.

In the first presentation, Alan Ryan, Director of National Transformation Programmes at Health Education England (HEE), discussed the education and training of pharmacists in light of changes to the NHS environment and the introduction of pharmacy reforms including new prescribing roles. He explained that HEE are working with a variety of partners to enable development and growth of the pharmacy profession.

This year is the first year HEE have implemented the foundation programme, based on learnings from the interim programme. An assessment strategy has been published and an e-portfolio is available to every foundation pharmacist in England. They provide very clear guidance and training materials for designated supervisors, and there is a huge amount of material and resources available for training pharmacists, curated from many sources.

When the General Pharmaceutical Council (GPhC) was formed around 2010, it aimed to regulate pharmacists, pharmacy technicians and pharmacies in Great Britain, and part of its remit was to reform pharmacists’ education programmes.

Pharmacist Education Reform

The education reforms based on the new standards published by GPhC will result in the undergraduate pharmacy degree being far more clinically based than previously, with students getting rotational clinical placements across all sectors.

HEE has worked closely with employers, GPhC and pharmacists to put in place a codesigned Interim Foundation Pharmacist Programme for pharmacists who were provisionally registered during the COVID-19 pandemic. This gave them the opportunity to trial the programme to see what works well in a foundation training scheme.

Further information about the initial education and training of pharmacists is available at: https://healtheducationyh. onlinesurveys.ac.uk/register-for-ietp-updates

GPhC have recently published new standards for pharmacist training which specify a set of learning outcomes which span the full five years of pharmacist 14

Pharmacy Technician and Pharmacy Support Staff Workforce Strategy

During the first phase of this, which ran from 2017 – 2021, the focus was on postgraduate pharmacist training, independent prescribing, supporting pharmacists to deliver safe and effective pharmaceutical services via NHS 111 and medicines optimisation in care homes.

This strategy was launched to coincide with the 10-year anniversary of registration for pharmacy technicians.

The initiative is around understanding what pharmacy technicians will be needed to do in the future.

In the second phase, running from 2021 – 2024, the funding will focus on independent prescribing and clinical examination skills.

Currently, the exact number of people working as pharmacy technicians is unknown, and there is a survey of community pharmacy in place to try and improve on this data. However, demand is growing for pharmacy technicians to support delivery of new service models outlined in the NHS long-term plan. There is also an increasing demand for technicians to be able to support pharmacists: as pharmacists undertake more and more clinical work, so the role of the pharmacy technician will need to evolve to take on more of the tasks previously done by pharmacists.

Providing Information and Advice – the UKMI experience The second presentation of the workshop was delivered

by Dave Abbott and Vanessa Chapman from UK Medicines Information (UKMI).

Dave gave a brief overview to explain that UKMI are an NHS based pharmacy service which aims to support the safe, effective and efficient use of medicines through the provision of evidence-based information and advice i.e. they answer questions from HCPs and patients and provide advice on how to get the most out of their medicines.

All pharmacy technicians are now trained via HEE funded apprenticeships, and an expansion programme has been launched to support the education and development of pharmacy technicians in primary care.

Pharmacy Integration Fund

UKMI is also part of the NHS Specialist Pharmacy Service, which supports medicines optimisation across the NHS.

This is focussed on community pharmacy and is around developing the pharmacy workforce to develop more clinical services.

The remit of UKMI pharmacists is effectively to find 15

CONFERENCE 2021 PRESENTATION SUMMARIES information and turn it into advice for the people who contact them for assistance. As a result, UKMI pharmacists are often heavy users of pharmaceutical MI departments.

User story 1: “As a community pharmacist, I want to safely sell some miconazole gel to a patient who’s on a statin so that I can treat the patient’s oral thrush or refer them to a prescriber, as necessary, and it’s done when I’ve made the referral”.

Dave shared some thoughts and considerations about what UKMI expect about the information they receive in response to an enquiry, as well as what they aim to do as providers of information. He then handed the presenting baton to Vanessa Chapman, who talked about UKMI’s role in developing content for the SPS website.

User story 2: “As a GP or prescriber, I want to decide whether my patient’s muscle pains are caused by their medication as they’re on miconazole and simvastatin, so that I can safely treat the oral thrush and lipids, and it’s done when miconazole or a suitable alternative has been prescribed.”

This website was initially developed around 4-5 years ago to consolidate information from about 15 different websites. The content is designed to solve problems for its end users and there is a lot of consideration put into how the information is displayed, who the audience is and what they are looking for.

Vanessa then discussed some case studies, looking at publishing both simple and complex content:

Over the past year, the website has had around 6 million hits: around 20,000 – 30,000 per day. Although the site is mainly used by HCPs in the UK, it is also accessed world-wide.

The UKMI firmly believe that the audience would be lost if content were to be hidden behind logins and multiple clicks, so it is freely available at all times: providing advice and guidance to HCPs 24/7.

Although there are multiple routes for content production on the SPS website, the starting point for much of it is user stories. This is a new way of working for the UKMI, and there is Government guidance on how to write these: https://www.gov.uk/service-manual/agile-delivery/writinguser-stories

Identifying content for the website happens in several ways – from identifying themes in frequently asked questions to working in focus groups to identify content requirements. This can be quite a lengthy process, as can the content development: it takes significant time to research, develop and review content before publishing and promoting it. After this, everything on the website must be maintained and updated to ensure it is current.

However, where content requirements are urgent – which has happened a lot in response to the need for urgent COVID advice – then the content can be turned around in a matter of days.

Vanessa used the following user stories as examples.

Here, fundamentally the same question is being asked (i.e. whether there is an interaction between miconazole and statins), and the information for the answer to each is effectively the same. BUT, the advice given on the website in response to each user story would be written in a completely different way for each one: 16

CONFERENCE 2021 PRESENTATION SUMMARIES Group Discussions

Hubinger and Mariska Lubbe from Pfizer. Mariska gave a brief overview of Pfizer MI and its vision to enable its customers to obtain information that is easily accessible and trusted via intuitive automated solutions. This is facilitated by seamless transactions across different channels, allowing customers access to global responses.

Following the presentation, Harpreet asked the speakers whether there is a forum or an opportunity for pharmaceutical companies, who hold a wealth of information, to input into the content of the SPS. Dave discussed the fact that UKMI often contact Pharma for data they need e.g. stability data. He acknowledges that there is a need for UKMI to be clear about what they are asking for, and that their members need to understand that Pharma are unable to provide advice – being only permitted to provide the information that can then be used to inform clinical decisions.

In the UK, most Pfizer customers are HCPs and request information mainly via the phone, but there has recently been an increase in use of other digital channels: these include optimised IVR – so that customers can self-serve via the telephone - and use of the Pfizer MI website via which customers can search standard response documents and other data published there. The website has recently been redesigned and includes a stability calculator for some of the company’s products, a chatbot and live chat functionality.

The workshop delegates then took some time to discuss whether MI teams could or should signpost enquirers to independent resources, such as the SPS website, even if they contain information and guidance on off-label use – using the advice on use of medications in patients with swallowing difficulties on the SPS website as an example.

Mariska also mentioned the MI Leaders in Europe (MILE) organisation, in which Pfizer plays an active role. Pfizer makes information available through the MILE gateway, which provides easy access to trusted MI resources to HCPs and patients on behalf of various pharmaceutical companies. This resource is available in 14 countries, including the UK.

Generally, there was nervousness around referring to such sources, and most agreed that the company’s legal department would need to be consulted regarding this, particularly if the source is known to provide information that is not in line with the SmPC. However, there was also discussion around whether such signposting could be carried out if appropriate disclaimers were to be used.

Finally, Mariska introduced Partner4Better - Pfizer’s global outreach programme that is designed to empower HCPs to deliver better patient outcomes through relevant educational content.

There was also concern about the collecting of safety data. If HCPs were signposted to the SPS page that recommends crushing a tablet for administration to a patient who has swallowing difficulties, who would have responsibility for ensuring the safety data is collected?

Gudrun then guided the delegates through further detail about Pfizer’s Partner4Better programme, which aims to address health education inequity. This is often an issue for low- and middle-income countries, but can be a problem globally.

It was agreed that although pharmaceutical MI teams can’t provide advice, they do have a role in supporting HCPs to make informed clinical decisions. It may be that such signposting can be permissible when done with clear and appropriate disclaimers. As PIPA has a strong working relationship with UKMI, it may be possible that appropriate disclaimers could be added to the SPS website to encourage the reporting of adverse events and off-label use.

Through her work in Africa, Gudrun became very aware of how challenging it is for HCPs on the continent to access medical information and clinical data. The idea of the programme was born at an International Federation of Pharmacists (FIP) conference around 5 years ago. Its aim is to offer training and education opportunities to support better access to health for all. It looks to improve safe and responsible use of medicines through innovation and education partnerships. The focus is on delivering education globally, above brand. The programme works in collaboration with different groups to leverage expertise to achieve a greater reach. There is also a focus on building trust with professional medical associations.

Pfizer – Partner4Better

Although the programme started in Africa, it has evolved through the Middle East into the rest of the world.

Partner4Better started hosting live events in 2017, and by

The final presentation of the day was delivered by Gudrun 17

CONFERENCE 2021 PRESENTATION SUMMARIES 2018 virtual events were introduced to enable increased access – including an event that was attended by over 700 HCPs in three African countries.

MI functions to connect with our HCP partners and support education and equity aims together? Are there any specific educational topics and expertise that we, as PIPA members, think are required? What channels work in European / UK markets to provide educational content? Can we work closer to fill educational gaps for HCPs, for pharmacists? Can we work together to achieve health equity? Pfizer firmly believe that, together, we can.

The Partner4Better programme is now offered via two

What next?

This workshop provided a fascinating insight into some of the resources available for educating HCPs to enable the safe and effective use of medicines, and ensure better outcomes for patients, both locally and globally.

PIPA’s aim is to continue to liaise with NHS England, UKMI and potentially other stakeholders to increase the opportunity for medical information functions in the pharmaceutical industry to input into such vital education opportunities. Many pharmaceutical companies produce valuable online resources for HCPs and patients and may simply require more visible signposting. This discussion will continue…

microsites – one global and one Chinese, due to the unique Chinese digital landscape. Currently there are 8 training modules that have been digitised, in 5 different languages reaching more than 20,000 HCPs. Although the programme is targeted at lower- and middle-income countries, it is accessed world-wide.

Partner4Better collaborates both internally, and externally, with stakeholders: Currently, the following modules are available via the resource: Pfizer continually collates and analyses its customer feedback. They now have validated feedback questions to help describe and understand the impact of the educational materials.

Anne Turnbull Operations Manager PIPA

Gudrun concluded the presentation with the following questions for the wider PIPA audience: could we ‘partner 4 better’ across the whole industry, agencies and other 18

CONFERENCE 2021 PRESENTATION SUMMARIES Medical Device Regulations

By Ka-Mei Au

Rob Higgins is a Senior Regulatory Affairs Manager at the Medicines and Healthcare products Regulatory Agency (MHRA) and has worked there for over 30 years. Rob has experience working in medical device legislation, reviewing clinical investigations, and monitoring Notified Bodies. His main responsibilities now include conducting inspections on medical device manufacturers, the assessment of UK Approved Bodies, and being involved in global harmonisation activities. With his expertise, Rob gave an overview of the recent and upcoming changes in EU and UK medical device regulations, key considerations medical device manufacturers should be aware of, and what inspectors look for in manufacturer inspections.

Background Rob’s presentation started with an overview of the existing medical device legislation in the UK which was implemented in 2002. This was based on three EU Directives: Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD) (see Figure 1). These will remain active in Great Britain until new regulations are implemented in 2023.

EU MDR and EU IVDR There are two new EU medical device regulations which are replacing the existing directives in EU Member States: • EU Medical Devices Regulation (MDR) – applies from 26 May 2021 • EU In Vitro Diagnostic Medical Devices Regulation (IVDR) – applies from 26 May 2022

Figure 1. The EU medical device regulations replacing the current EU directives

The implementation of these new regulations will result in the following changes: • Updated medical device definitions and classification (see Figure 2) • A stronger post marketing surveillance system • The requirement for a person responsible for regulatory compliance – similar to a qualified person responsible for pharmacovigilance (QPPV)

19

CONFERENCE 2021 PRESENTATION SUMMARIES Specific changes implemented by the IVDR:

• Unique device identification (UDI) for devices • New requirements for medical device importers and distributers

• Expanded definition of in vitro diagnostic devices e.g. companion diagnostic tools, software etc. (previously there was no detail on software)

Specific changes implemented by the MDR:

• New classification requires increased scrutiny by Notified Bodies – previously only 10% of in vitro diagnostic devices required approval by a Notified Body. Under this new regulation, 80-90% of these devices will require approval

• Includes devices incorporating non-viable human tissues/cells • Includes products similar to medical devices but have an aesthetic purpose e.g. plano contact lenses, dermal fillers

• More detailed information will be required concerning the analytical and clinical performance of a device

• Reclassification of many medical devices to higher risk classes • New classification for reusable surgical devices will require Notified Body oversight

• Sufficient demonstration of clinical benefits and safety will be required

• Most companies will need to update clinical data, technical documentation and labelling

• Summary of Safety and Clinical Performance for Class C and D devices will be needed

• Summary of Safety and Clinical Performances is required for implantable devices and Class III devices

Figure 2. Classification system for different medical devices 20

CONFERENCE 2021 PRESENTATION SUMMARIES UK medical device regulations

Registration of medical devices in GB

Since these new EU regulations did not take effect during the Brexit transition period, they were not EU law automatically retained by the EU Withdrawal Agreement Act and, therefore, will not automatically apply in Great Britain.

Previously, medical device manufacturers only had to register in one EU Member State but now, if manufacturers want to sell into GB, the device must be registered first in GB. To register a medical device with the MHRA, it must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023).

From January 2021, the MHRA have been working to develop a new domestic regulatory framework for medical devices. International standards, best practice and global harmonisation are being taken into consideration. A consultation on the future regulation of medical devices in the UK was opened by the MHRA on 16 September 2021, which invited members of the public and those in the industry to share their views on the matter.1 The MHRA also held two webinars in October 2021 to provide people with more background knowledge. The consultation closed on 25 November 2021.

UK Responsible Person If manufacturers based outside of the UK wish to place a device on the GB market, the product must be registered with the MHRA beforehand. The manufacturer should therefore appoint a UK Responsible Person (UK RP), who is established in the UK, to do this. This requirement has been implemented since 01 January 2021.

Figure 3. Registration dates for different medical devices in GB

CE and UKCA marking in Great Britain (GB)

Northern Ireland

CE marking is still valid in the UK until 30 June 2023.

The Northern Ireland Protocol, which was agreed upon in October 2019, allows Northern Ireland to follow different rules for placing medical devices on the market:

The UK Conformity Assessed (UKCA) marking is a new marking for UK goods being placed on the market in

• NI will continue to have access to the EU Single Market and will follow EU legislation

GB and will replace the CE marking. UKCA marking is now valid for medical devices marketed in GB and will

• As with the other EU Member States, NI will implement the EU MDR and EU IVDR from 26 May 2021 and 26 May 2022 respectively

become mandatory from 01 July 2023. A UK Approved Body, which replaces UK Notified Bodies, must be used to obtain the UKCA mark. They cannot conduct conformity

• CE marking, which will be applied by an EU Notified Body, will still be required for medical devices

assessments for the CE mark.

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CONFERENCE 2021 PRESENTATION SUMMARIES

Figure 4. Timeline overview of key actions in GB

• If a third-party conformity assessment is required for a device, the UKNI marking can be applied by a UK Notified Body. The UKNI marking does not replace the CE marking and is valid for the NI market only

which also normally includes certification against ISO 13485:2016.

Key elements of ISO 13485 include: • General requirements e.g. document control, technical files

MHRA market surveillance

• Management responsibility e.g. management review

The MHRA carries out risk-based market surveillance activities which involves proactive and reactive actions.

Their proactive activities involve:

• Resource management e.g. making sure personnel are all trained; infrastructure of building

• Checking medical devices on the market to ensure compliance

• Product realisation: where production and testing take place

• Monitoring the safety of the devices

• Measurement, analysis and improvement e.g. AE investigation, reporting to Regulatory Authorities, internal audits

• Ensuring the devices work as intended by the manufacturer and that they deliver the intended benefits

These key elements were expanded upon:

Direct audits and inspections are some of the tools that are used by the MHRA to improve the effectiveness and efficiency of market surveillance. These activities are not intended to undertake the role of a UK Approved Body/ EU Notified Body, but rather to complement the inspections conducted by these Bodies.

Management responsibility • Top management should review the organisation’s quality management system (QMS), at annual intervals

MHRA audits/inspections

• They should refer to ISO 13485, which lists what should be included in these reviews

Rob then talked us through the key issues that are often identified in MHRA inspections of medical device manufacturers. He explained that medical device manufacturers of medium and high risk devices must have certification from a UK Approved/EU Notified Body

• The review of new regulatory requirements is often poorly done. In recent inspections, Rob has noted that many management review meetings have not taken into account the changing requirements imposed by the new EU regulations 22

CONFERENCE 2021 PRESENTATION SUMMARIES Product Realisation

• Manufacturers should have documented procedures for the control of a product with a limited shelf life or those requiring special storage conditions

• Planning • Customer related processes

• A common finding in inspections is that the monitoring of their storage conditions is inadequate as fridges and freezers are not monitored properly. Important considerations that should be made such as what measures are in place if a fridge/freezer fails, or if the doors have been left open for too long

• Design and development: • Validation is an important step to ensure the product can meet the requirements for its intended use • This requires clinical or performance evaluation(s) to be carried out: • Can be done with clinical trial evaluations or literature reviews. However, Rob remarked that the latter is looked at less favourably these days

• Control of monitoring and measuring devices Measurement, analysis and improvement – monitoring and measurement involves: • Manufacturers receive feedback including customer complaints/vigilance:

• Rob explained how clinical evaluations for the design and development of devices is one of the most poorly done areas. He recalls instances where manufacturers have claimed a device is equivalent to another but is in fact very different and where the literature used in their reviews are not relevant to the devices they are developing

• Manufacturers are legally obligated to report SAEs they become aware of to the regulatory authorities

• Purchasing: • This area is generally done well as the requirements are quite clear-cut • Purchased products should conform to specified purchase requirements and the purchasing information should describe the product • Verification of purchased product • Product and service provision • Validation of processes: • Processes where the resulting output cannot be verified by subsequent monitoring or measurement should be validated e.g. sterilisation processes should be validated prior to initial use • Can be costly to validate these processes • Overall, this is done reasonably well • Identification and traceability • Preservation of product: • Includes identification, handling, storage and protection 23

CONFERENCE 2021 PRESENTATION SUMMARIES • However, a common finding in inspections is that they do not – possibly for fear of having the authority conduct investigations into the company

• Work environment: • Health cleanliness, clothing of personnel, suitable airflow through facilities • Special work environment conditions and their monitoring

• Post marketing surveillance:

• An area of concern is that the fabrics seen in controlled environments are not always suitable

• This includes literature screening of equivalent products, going through notices from the authorities and collecting proactive feedback from users

Technical file reviews: • Technical files are sometimes pulled off site in inspections

• This is also a weak area in inspections – many companies are not proactive enough to do more than handle customer complaints

• This is the biggest area of concern for compliance, even in companies that have been approved by Notified Bodies

• Suggested that internal audits should be carried out annually to determine whether the QMS conforms to regulations and ensure it is effectively implemented

• Main areas of concern in technical file reviews include: • Declaration of conformity

Resource management involves:

• Classification – sometimes this is wrong

• Competence, awareness and training of staff:

• Clinical/performance evaluation – can be very poor

• The organisation should: • Determine the competency necessary for personnel performing work which affects product quality

• Risk management – can be poor • Biological safety evaluation • Electrical safety

• Provide training and evaluate effectiveness of the training

• Electromagnetic compatibility • Packaging and labelling

• Maintain training records

• Sterilisation validation

• Rob finds it concerning that organisations do not always send their regulatory staff on courses to understand regulations and quality system standards

• Stability studies 1. Consultation on the future regulation of medical devices in the United Kingdom - GOV.UK (www.gov.uk)

• As a result, Rob often finds that the Regulatory Affairs Manager is not up to date on changes in regulations • However, it has been noted that manufacturers are generally good at training the assembly staff and those involved in production • Infrastructure: • Appropriate buildings, workspaces, associated utilities

Ka-Mei Au Drive Phase PV

• Process equipment (hardware and software) including their maintenance • Supporting services 24

CONFERENCE 2021 PRESENTATION SUMMARIES Implementing Conversational AI Solutions in Medical Information 2 case studies outlining business and operational considerations

By Shailini Blackwell

Pharmaceutical companies continue to accelerate their interest in, and deployment of, conversational artificial intelligence (AI) – text or voice virtual assistants – to support medical functions including Medical Information. At our recent PIPA Conference in September 2021, Orion Pharma (UK) Ltd. (together with their partner, conversationHEALTH) and Lifelink Systems overviewed process and strategic considerations as well as outcomes for PIPA members to consider when looking to implement a solution.

Julie Boothe; Orion Pharma UK Shailini Blackwell; conversationHEALTH Justin Mardjuki; Lifelink Systems

The case for change – customers want to engage digitally, 24/7, with one business

now have the ability to augment current teams with conversational AI which can double or triple the number of touchpoints we have with patients”

With healthcare professional (HCP) and patient behaviour and expectations having shifted over the past 18 months to a digital-first business engagement, the opportunity for Medical Information (MI) departments to capitalise on technology is very much “now”. As Justin Mardjuki from Lifelink Systems shared, 97% of text messages are opened in less than 3 minutes, and this is not just driven by friends and family but now transcends engagement with business, social and other day-to-day engagements.

However, as Julie noted, this requires multiple stakeholders across the organisation to come together to explore the requirements, skillsets and outcomes for an enterprise solution. First for Julie was Commercial. “Our customers are the same, they don’t see us as medical or commercial, they see us as one organisation. There is a need to fit the business strategy and ensure that customers are getting the best experience when engaging with Orion”.

Medical Information are now “front-of-house” – the gateway to the business as HCPs demand scientific content with as little hassle as possible when it comes to access and authenticity. As Julie Boothe, from Orion Pharma, identified for her organisation “Customers want to get in contact with the company, get their response and leave”. Justin agreed from the patient perspective “Patients get stuck in the middle of pharma’s siloes…. we need to remove the friction for patient experience and make it as humanly-easy as possible”.

Alongside Commercial, we need to ensure there is a seat at the table for Legal, Compliance, PV, Data Privacy, IT, Regulatory and QA/validation leads to the groundwork being in place from the outset to support global scaling across the organisation, rather than just a pilot or one market approach.

It means automation of workflows and processes that will drive a change management strategy for the human workforce alongside technology has a 360° business view applied to it immediately, facilitating accelerated growth across the business. As quoted in a recent paper from IQVIA, “Automated agents are better and faster at responding to simple inquiries and reviewing documents, freeing live agents to do more value-added work.”

Change management – the need for a multidisciplinary approach The use of conversational AI across pharma and life sciences continues to accelerate and MI is a cornerstone of this adoption. With a need to increase reach and accessibility to customers as well as a real opportunity to digitally transform legacy systems and processes, MI teams across pharma are looking to automation as a means of freeing up human headcount for businesscritical and strategic work. As Justin highlighted, “We

Regulatory and Compliance Validation requirements are a critical component for consideration and approval of an enterprise conversational AI solution: ensuring all requirements are 25

CONFERENCE 2021 PRESENTATION SUMMARIES met for audit and regulatory/compliance.

understood that humans alone would not reach this goal.

Leveraging conversational AI meant:

A refreshing realisation, Julie noted, was that many existing SOPs and processes for validation and QA were applicable to this new technology - “The organisation soon realised they had a lot of knowledge and capabilities to readily apply to this new technology.” This saved time and, crucially, expanded the interest and organisational excitement to bring in this new channel for customer engagement.

1. The ability to enrol patients, identify local sites to patients and schedule first visits through a digital engagement 2. A reduction of trial recruitment timeline to 3 days 3. A high patient satisfaction level, with 93% preferring the chatbot over traditional phone methods

Another “penny drop moment” as Julie described it, was the realisation that many of the existing workflows for training and deploying human staff (e.g. outsourced call centres, internal staff) would be applicable to the conversational AI agent.

Data shared by conversationHEALTH about their medical applications in the global market indicates a significant reflection of customer behaviours today – wanting 24/7 access at a time and in a channel that suits them, and that, if done well, will improve customer satisfaction:

Early results – improving reach, engagement and customer satisfaction

• 40% usage out of hours

But are HCPs and patients engaging in such text and voice virtual assistants to communicate with pharma, its brands and services? The answer is a resounding yes.

• >96% of questions successfully managed by the conversational AI agent

• 4.5 satisfaction rating

AI-powered virtual agents – enabling a new, hybrid model for MI to engage with customers

One case study presented by Justin from Lifelink Systems - on clinical trial recruitment and site visit bookings for the Operation Warp Speed Phase 3 COVID-19 trial demonstrated impressive results. For such a large-scale trial, needing to recruit tens of thousands of patients in a matter of days (rather than years), it was clearly

Conversational AI continues to represent an exciting digital tool that is rapidly being deployed both globally

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CONFERENCE 2021 PRESENTATION SUMMARIES

and regionally by pharma and life sciences companies to enhance MI services and capabilities. By freeing up the time of experienced MI teams to do more business- and strategic - work, automation through AI-powered agents also brings a smart, digital-first channel into the mix for scientific exchange between customer and company.

Having humans working with and alongside technology in a hybrid model that is easy, seamless and provides greater insight into customer needs will only benefit brands and teams in the future.

References: https://www.iqvia.com/en/library/white-papers/the-truth-aboutconversational-ai

Shailini Blackwell Managing Director, Europe conversationHEALTH

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29/04/2019 11:09

MANAGEMENT OF PRODUCT INFORMATION – Summary of PIPA Webinar

By Charlotte Mason

In March 2021, Harpreet Sandhu, from the PIPA Committee, presented a PIPA MI webinar on the management of product information. Harpreet was joined by Nat Knight and Claire Cox from Datapharm. The session was structured around these topics: - The Ireland/Northern Ireland Protocol - The importance of the NHS Dictionary of Medicines and Devices (dm+d) and keeping it up to date - Best practice on managing digital prescribing information In this article, I have summarised the salient points relating to the Protocol on Ireland/Northern Ireland and the NHS Dictionary of Medicines and Devices.

Protocol on Ireland/Northern Ireland Claire and Nat kicked off the webinar with an explanation of the various marketing authorisation (MA) procedures and what has changed with the implementation of the Ireland/Northern Ireland Protocol.

Essentially, since the end of the transition period on 31-December-2020, the Ireland/Northern Ireland protocol applies. Medicines that are marketed in Northern Ireland fall under different obligations than the rest of the UK. From 1 January 2021, EU pharmaceutical law applies to the UK in respect of Northern Ireland only. All Pharmaceutical companies had until 31 December 2020 to ensure that their centrally and nationally authorised medicines complied with EU law in order to remain on the EU market.

• Decentralised and Mutual Recognition Procedures • National Procedures • Unfettered Access Procedures Centralised Procedures Products that were approved by the European Medicines Agency (EMA) are centrally approved products (CAPS). All existing CAP MAs automatically converted into UK MAs, effective in GB only. As a result of the Ireland/Northern Ireland Protocol, existing CAPs will remain valid in NI.

According to the Ireland/Northern Ireland protocol, the national MAs for medicinal products issued by the United Kingdom in respect of Northern Ireland, UK(NI), must comply with Article 17 and 18 of Directive 2001/83/EC, i.e. they have to go through the decentralised procedure (DCP) or the mutual recognition procedure (MRP) if the applicant already holds an MA for the same product in an EU/EEA member state (MRP), or applies for MAs for the same product in any EU/EEA member state(s) (DCP).

Under the Ireland/Northern Ireland Protocol, Medicinal Products authorised via the centralised route will be directly authorised for use in Northern Ireland. Any variations to these Marketing Authorisations will be centrally managed by the EMA in accordance with relevant procedures. A separate MA will not need to be issued by the Medicines and Healthcare products

There are several different Marketing Authorisation application procedures: • Centralised Procedures 29

Regulatory Agency (MHRA) for Northern Ireland.

The dm+d provides [1]:

Decentralised and Mutual Recognition Procedures

• The recognised NHS standard for uniquely identifying medicines and medical devices used in patient care

Under the Ireland/Northern Ireland Protocol, Medicinal Products authorised via the mutual recognition procedure/ decentralised procedure from 1 January 2021, where Northern Ireland is specifically included as a concerned member state (CMS), may be authorised for use in Northern Ireland only.

• Clear, consistent recording and communication of information relating to medicines and devices used in patient care • Consistency in how medicines and medical devices are written through a robust published editorial policy

National Procedures Under the national procedure, the MHRA can grant MAs for UK, GB, or NI. MAs authorised in the UK by the MHRA before 1st Jan 2021 continue to have effect across the UK (GB & NI). This includes MAs that are currently, and will continue to be, part of any MRP/DCP. For new active substances there is a Rolling Review route.

The Standardisation Committee for Care Information (SCCI) has approved the dm+d as the NHS standard for communicating medicines information. [1] What information is stored in the dm+d database?

The dm+d contains standardised codes, descriptions and metadata for every product entry as well as the following [1]:

Unfettered Access Procedures Unfettered Access Procedures (UAP) relate to MAs approved in Northern Ireland. This procedure allows Great Britain MA approval for an existing MA that covers Northern Ireland and is available to NI MAs approved via centralised procedures or MRPs/DCPs.

• whether a product will be reimbursed by the NHS, if submitted for reimbursement by a dispensing contractor • the indicative price of each pack of a product (where a price is maintained by the NHS)

The NHS Dictionary of Medicines and Devices (dm+d)

• current and discontinued products and packs available from manufacturers and suppliers

What is the dm+d database?

The NHS Dictionary of Medicines and Devices (dm+d) is the standard dictionary for the medicines and devices used across the NHS.

When to update dm+d Harpreet formulated a checklist of situations where you will need to update the dm+d with information about your

30

informative and insightful. I’d like to thank the presenters, Harpreet, Nat, and Claire for their efforts. I hope our MI members also found it beneficial.

company’s products. I have created the graphic below to illustrate the checklist: The process will vary from company to company, in terms of which department is responsible for updating dm+d about product changes. You can check the emc (www. medicines.org.uk) website for further details on the service they offer for updating dm+d, or you can contact the NHS Business Service Authority (BSA) directly to provide updates on your company’s products:

Don’t forget - we always welcome ideas for topics for our webinars. If you have an idea for one or would like to help present on a particular subject, please do get in touch via pipa@pipaonline.org. We would really like to collaborate with the PIPA membership and present medical information topics that you are interested in and find relevant to the industry.

www.nhsbsa.nhs.uk/nhs-prescription-services If you’d like to learn more about dm+d, I can recommend spending 10 minutes watching a webinar on what the dm+d database is, the background to its implementation and why it is so important for the NHS.

References The NHS Dictionary of Medicines and Devices (dm+d) website: [Last accessed 04-Nov-2021]

The introductory webinar is accessible via the following website:

Charlotte Mason

https://dmdlearning.s3.eu-west-2.amazonaws.com/ dmd_Introduction/index.html

Associate Director Medical Information Jazz Pharmaceuticals

I was grateful to have the opportunity to watch the recording of this PIPA webinar and I found it to be very 31

LOOKING AFTER YOUR SLEEP

By Lisa Artis

Like proper nutrition and exercise, sleep fulfils a vital role in keeping us healthy and happy. We need a good night’s sleep to ensure we’re feeling fit, thinking sharply and generally to give us the appetite and enthusiasm to make the most of everyday living. However, poor sleep and fatigue are common problems, affecting millions of people world-wide.

We spend a third of our lives sleeping. It’s vital to our health and wellbeing. And yet we don’t always pay enough attention to why we need it. People go to huge amounts of time and expense to eat well and exercise regularly, but without a good night’s sleep all that effort will be in vain.

ways of relaxing. This could be listening to soothing music, reading, doing some gentle yoga or meditating.

If you struggle to sleep or wake in the middle of the night with your mind – and heart - racing, try to practice some deep breathing techniques. If your mind is buzzing with things to do, write them down. Speaking positive thoughts aloud can help too.

Sleep doesn’t just make us feel better, it can improve our health by decreasing the risk of heart attacks, diabetes, strokes and it helps us fight off minor ailments, deal better with depression and even tackle weight problems.

Don’t try to sleep – it needs to find you. Keep your eyes open and gently resist sleep or try to adopt a carefree, accepting attitude to wakefulness. Avoid clock watching if you can’t get to sleep within 15 minutes from switching the light off then get up and go to another room and doing something relaxing.

Lack of sleep diminishes levels of concentration and makes you liable to swings in temper and depression.

Sleep affects our learning and problem-solving capabilities. The more REM sleep (dream sleep) we have, the easier it is to retain things that were learned the day before. Problems that appear insoluble can become clear in the morning.

SLEEP IS INDIVIDUAL Our sleep isn’t always the same and certainly isn’t always ‘perfect’ depending on what’s going on with our lives and how well we look after ourselves. It’s not uncommon to have an odd night of unrest but it’s important this doesn’t become a regular occurrence.

GOOD SLEEP AND LIFESTYLE HABITS So how do we sleep better? To ensure you experience good sleep it’s essential to follow good lifestyle habits and to eliminate the factors that are causing you disturbed sleep.

The key to getting a good night’s sleep is routine: keeping regular hours and going to bed and getting up at roughly the same time every day. This will help to programme the body to sleep better.

First make sure your bedroom is conducive for sleep.

A restful bedroom environment should ideally be cool, quiet and dark and free from distractions – that means removing computers, tablets, mobile phones and even TVs. Avoid screen time at least an hour before bed as the blue light that emits from these devices suppresses the sleep-inducing hormone, melatonin. Comfort - whether that’s the bed or the bedding - also plays a large part in optimising sleep. It’s difficult to get deep, restful sleep on an old, uncomfortable bed. Use adequate bed clothes and pillows.

We also shouldn’t get too hung up on the number of hours we sleep – quality over quantity – remember one size doesn’t fit all. Some of us cope perfectly well on 6.5 hours of sleep whereas some of us need nearer to 9. The best way to determine if you’re getting enough sleep is to look at how you feel the next day. Being tired doesn’t mean you’ve not had enough sleep. However, if you feel sleepy, exhausted and unable to function then chances are you are not sleeping well.

The next factor is a proper bedtime routine. You should be aiming to wind down at least an hour before bed. Do something that you find enjoyable and find alternative 32

HOW TO LOOK AFTER OUR SLEEP

without further intervention like Cognitive Behavioural Therapy for Insomnia which looks at sleep restriction therapy (restricting the amount of time in bed) and stimulus control (creating a strong association between sleep and the bed).

How we sleep affects how we feel about areas of our life – whether that’s our mood, our relationships and even our work – which is why we need to protect it.

Start by having a good morning routine. Try to wake up at a similar time, and avoid lengthy lie-ins, to strengthen the body clock and, where possible, expose yourself to natural light in the morning to suppress melatonin and boost alertness.

Sleep is the number one way to improve your lifestyle.

For more information visit thesleepcharity.org.uk or contact info@thesleepcharity.org.uk

Consider what you do during the day that may impact on sleep. For instance, if you are sensitive to caffeine, avoid it 8 hours before bed so it doesn’t interfere with getting off to sleep. Exercise is great for sleep, and for mental health, but try to do it earlier in the day rather than before bedtime.

Lisa Artis Deputy CEO The Sleep Charity

For anyone who has been suffering with long-term insomnia, sleepy hygiene strategies will not be effective 33

PHARMACOVIGILANCE THROUGH MERGERS AND ACQUISITIONS

By Tom Nichols

Mergers and acquisitions (M&A) are an everyday part of the pharmaceutical industry. Whether it involves acquisitions of companies (complete or partial) with the integration of departments, or ‘just’ the sale of assets, M&As are something that we will all have to deal with at some point in our careers. There is no one-size-fits-all approach to pharmacovigilance (PV) during M&A activities, and they are mainly driven by the wider commercial approach being taken by the companies involved. This article looks at some of the key considerations involved.

Such is the ubiquity of M&A, Good Vigilance Practice (GvP) Module I ‘Pharmacovigilance systems and their quality systems’ specifically mentions it:

PV departments and expect them to pick up the pieces.

However, the best way to avoid this happening is to proactively foster relationships with the wider business and senior decision makers, so everyone is aware of this in advance. Much more difficult to try and amend things after the event, even if you are given authority by your company.

“When a marketing authorisation holder intends to expand its product portfolio, for example, by acquisition of another company or by purchasing individual products from another marketing authorisation holder, the QPPV should be notified as early as possible in the due diligence process in order that the potential impact on the pharmacovigilance system can be assessed and the system be adapted accordingly. The QPPV may also have a role in determining what pharmacovigilance data should be requested from the other company, either pre- or postacquisition. In this situation, the QPPV should be made aware of the sections of the contractual arrangements that relate to responsibilities for pharmacovigilance activities and safety data exchange and have the authority to request amendments.”1

While this article will focus on some of the practical considerations involved in M&A, changing a PV system is not just a series of faceless processes and systems being updated. The human aspect is, if anything, more important. Even though processes and systems are drummed into us, I have never seen a PV system that doesn’t also lean on human knowledge. Even down to the mundane “where can I find this document?”. The PV changes can be sold to people as development opportunities, but it’s very difficult to come up with the advantages of potential redundancies or having to relocate. Even the importance of development opportunities can take a bit of time and distance to understand and appreciate, as I can personally attest.

It is vital to manage engagement and communication throughout, as both key messages and staff moral can be undermined without it. Differences in view between ‘the company’ and staff on the ground can often not be more different. It is also important to be aware of differences in work culture and employment rights around the world (for example, between the EU and US), so attitudes may be quite divergent.

The FDA also recognise it as an area that should not detract from the successful completion of PV activities: “When inspecting firms undergoing corporate transitions, determine that written procedures have been appropriately updated to ensure that the surveillance, receipt, evaluation, and reporting of PADEs remains in a state of compliance.”2 Although there is this regulatory requirement to be involved as soon as possible in the due diligence process, in reality this often doesn’t happen, and PV departments are having to fight reactively. The key words here I think are the QPPV having the “authority to request amendments” to the contracts and safety data exchange agreements (SDEAs). This shouldn’t just be dropped on

The following table provides just a few, high level, key considerations for when you approach any merger or acquisition. For all these, you must remember that PV does not work in isolation. Liaison with regulatory is essential for Eudravigilance updates and with Legal 34

for safety data exchange agreements (SDEA) etc.

Consideration also needs to be given to resourcing and the extent to which there is the internal expertise to manage the various strands of the project. It may be

possible to deliver certain elements in-house but have to bring in external expertise for others. It is as important to know what you don’t know in these situations, as it is to know what you know!

Strategy

It’s very easy, and common, for ‘strategy’ to be thrown around as a necessary buzz word without actually doing what it is meant to do. It needs to be decided in advance and inform every other decision that is made. It’s not getting stuck in the detail of ‘how’ but it’s a picture of where you want to get to. “We’re going to integrate PV” is not a strategy. “We are going to centralise global PV activities, while retaining affiliate expertise to fulfil local obligations” is.

Different companies’ PV departments will have different working relationships with other departments and some may have been hard won. The strategy should guide you but not be restrictive to the point of ending up with a poorer PV system. For example, you may want everything to be subsumed into Company A’s system but find that Company B has an objectively better way of working with their regulatory team. Rather than throw the baby out with the bathwater, can you roll that way of working out across the new organisation?

Timelines

Timelines are very rarely exclusively driven by PV. The sooner the PV team is involved in the process then the more realistic the timelines can be.

Business Continuity

It is essential to ensure business continuity and maintain patient safety standards throughout the integration. Consider what regulatory activities are due during the transition period. For instance, do PBRER requirements lead to a prioritisation of certain actives being migrated in the database first, or left until last as manual production minimises risk?

Safety Database

The future use and the integration of different databases must be considered.

• Future case processing strategy and structure (i.e. central processing vs affiliate processing) • Migrations: • Duplicates • Configurations • Data structure (i.e. different databases, R2 vs R3) • Conventions • Training • Archiving • Audit trails Safety Data Exchange Agreements

SDEAs are difficult to manage, especially in big companies. A poll on a previous webinar suggested that both legal and PV manage contracts (i.e. not a single repository of information), so this can immediately lead to confusion over amendments and changing requirements. For example, there may be different formats and requirements depending on age, which involved party’s template was used etc.

Eudravigilance

Updates to EXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) entries, following licence transfers, and changes in Eudravigilance company IDs or Gateway settings need to be considered before activities can be safely and successfully transferred.

Pharmacovigilance System Master File (PSMF)

The PSMF will feed from the overall strategy, but how will multiple PV systems be maintained, in the short-term at least? Does a cut-over to a single, integrated, PSMF need to be rapidly developed?

It’s a general good tip to not lose sight of existing open CAPAs ,or forget historical instances, when bringing new products or companies on board.

References 1

Good Vigilance Practice (GvP) Module I ‘Pharmacovigilance systems and their quality systems’

2

FDA CHAPTER 53 - Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products

Tom NIchols PIPA President

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SMART SEARCH AND MODERN MEDICAL INFORMATION (MI) DELIVER VALUE FOR YOUR TEAMS AND THE WIDER BUSINESS

By Dr. Keith Tsui and Dr. Paul Riley

Artificial Intelligence (AI) and Natural Language Processing (NLP) technologies can be used to deliver smart search for healthcare and life science organisations, improving efficiency and providing data insights to customer thinking and behaviour. Here’s how.

It’s Monday morning — your list of projects is still there from last week, including plans and initiatives to help you and the team work smarter. You need to get on with these things, you acknowledge, because the battle to manage the growing workload is ever-present, and there is no end to the number of publications and sources of information you need to manage to be able to do your job. But at times, it is overwhelming.

Employing more people would help, but that’s not on the horizon. Technology is the answer, the company leaders are saying, when talking about the mountain of work the company needs to get through this year and next. But introducing technology is not straightforward: there are hoops to jump through, people to consult, budgets to secure. And who has time for that?

If your company isn’t already using AI and NLP, or at least working out how best to adopt it, you are at risk of falling behind the curve. The pharma industry is adopting digital technology at pace: large and small medical information teams worldwide are already using AI-powered products and services to improve quality and efficiency - the notion that AI & NLP is for other companies, or something to consider next year, is misplaced. The technology is here today, and to not use it may mean that your company is missing out on a valuable business asset.

Healthcare professionals (HCPs) are increasingly adopting a multitude of AI-powered technologies to improve the speed and precision of medical interventions for patients.

The technology is also used behind the scenes, helping manage surgical schedules, patient appointments, medical records, and more. Its use in other industries is commonplace.

This issue of excessive workload and keeping up with technology isn’t just found in pharma – it is affecting all industries. Artificial intelligence (AI) was once considered more of a sci-fi term than one you would encounter during your daily life. But AI is now commonplace, accomplishing both simple and more complex tasks to help speed up processes that take humans considerably longer to do. Natural language processing (NLP) may be unfamiliar to many of us, but it is in routine use in many industries, and you are likely benefiting from it regularly. Google Search, for example, uses both AI and cutting-edge NLP technologies.

The great news for medical information teams is that introducing AI and NLP to your processes doesn’t need to be a journey into the unknown. The technology is tried and tested, and the risks are known, as are the measures to mitigate those risks. That said, the perceived newness of the technology means people worry about whether they can trust the results generated by AI and NLP-powered processes. There are plenty of examples of how AI and NLP have enabled companies to cover more ground in a shorter time; for example, enabling the 36

visiting your platforms during the launch period for a new product, helping you to understand what aspects they were particularly interested in, what their concerns are, or if there any ways to improve communication around the product. Perhaps they are asking questions you hadn’t even considered?

review of hundreds of clinical papers in a fraction of the time it would take a medical information professional to carry out the task. And whilst it is true that there is a risk of relevant information being missed or misinterpreted, the testing that occurs during the set-up phase ensures that the risk of this happening is acceptably low – maybe lower than could be achieved by a human having to deal with the same volume of information.

The adoption of AI and NLP is a normal part of the evolution of medical information. Those with lots of experience in the industry will be familiar with the regular patterns of technology adoption, such as updates to medical information management platforms, regular iterations of electronic compliance systems, and the adoption of chatbots. In the future, AI and NLP technologies may not be prominent topics of discussion, but you can be sure that the products and services that use them are as they become more mainstream and are eventually simply the way things are done. It is inevitable; how else will pharma be able to manage the everincreasing amount of clinical and scientific information?

Yet many people in the pharma industry appear reluctant or wary of adopting AI and NLP powered systems; they are only slowly getting used to the idea of AI and NLP as a productivity enabler rather than a novel technology.

The opportunities for productivity gains in pharma are substantial, but the industry is conservative and highly regulated, so perhaps it is understandable that companies are cautious about embracing a perceived ‘new’ technology. Outside pharma, in the clinical setting, AI and NLP technology is being used widely by healthcare professionals to help them manage patients.

As an example, the medwise.ai platform enables HCPs to quickly find answers to their medical queries at the point of care. Such search platform tools are used by healthcare professionals at integrated care systems in the NHS, who are overwhelmed by the available information and cannot afford to spend time trawling through lots of information to find what they are looking for. The platforms can retrieve the specific piece of information they need within seconds, rather than the minutes or longer it would otherwise take.

As with any new technology, there will of course need to be a period of training for those people who will be using systems powered by AI and NLP. There will also need to be system validation, as well as reassurance about issues of data privacy, Code compliance, and suchlike.

But none of this is new; managing such issues is familiar territory for seasoned drug safety and medical information professionals.

For further information about the role of AI and NLP in medical information, or to request our free 30minute training package, please contact keith@medwise.ai

Such search platform tools can also be introduced by medical information teams to allow you to find the answers to enquiries from within and outside the company much more quickly than before, and you can be confident that every article in your literature repository has been scanned systematically, avoiding the risk that you miss key pieces of information.

Thank you to our colleagues Hannes Rox and Enea Polotti for reviewing the article.

But there are other aspects of this technology that create exciting new possibilities for pharma. There could be real value in embedding the technology on your platforms – company and product websites, customer-facing information hubs – and making it available for your customers to use for their own searches. You could empower your customers by providing them with a sophisticated search tool of your carefully curated information repository. You could review a summary of your users’ search activity over time to spot patterns or trends in what people are searching for. This information is of value to colleagues in the drug safety, medical affairs and marketing teams. For example, you’ll be able to share reports with your marketing team showing the searches undertaken by HCPs

Dr. Keith Tsui, MBBS, MPhil (Cantab) CEO and Co-founder Medwise AI Ltd

Dr. Paul Riley, MBA PhD CMgr Medical Affairs Director Glasshouse Health

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CONTINUING PROFESSIONAL DEVELOPMENT AND PIPA ACCREDITATION

By Anne Turnbull

During 2010, PIPA became a professional accreditation association with an associated Continuing Professional Development (CPD) points system of membership. There are several different types of membership, each with increasing requirements for eligibility and, where appropriate, a post nominal. This enables individuals to move through the levels of membership as they develop their career in Medical Information and/or Pharmacovigilance. access your complete CPD record at any time.

PIPA believes that this champions Medical Information and Pharmacovigilance as professions in the pharmaceutical industry. PIPA wants membership to be seen by employers as a necessity in developing and maintaining standards in the fields of MI and PV.

As well as this, achieving 40 PIPA CPD points over a 2-year period will allow you to qualify for higher PIPA membership – either Full or Fellow – depending on your experience. Higher PIPA membership entitles you to use postnominals of either MPIPA or FPIPA after your name, to demonstrate your industry experience.

In 2021, PIPA launched its CPD portal, which members can access via their ‘My Account’ button when logged in to the PIPA website:

What are the membership levels?

The idea behind the portal is that you can use it as a one-stop-shop to log all of your training and professional development achievements in one place. You can add historical CPD records going back as long as you would like. This means that even if you change companies, you will be able to

We have 5 levels of membership as outlined in the image below (which can also be found on the website: https:// pipaonline.org/professional-development/continuingprofessional-development/).

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With the exception of student members, everyone is automatically awarded Associate Membership when joining PIPA. Members can move up to full member (MPIPA) if they can demonstrate at least two years of experience in MI or PV along with at least 40 CPD points within the previous two-year period. The next membership level is Fellow (FPIPA), which is for professionals with at least 10 years of experience in PV or MI and a minimum of 40 CPD points in the previous two years.

• presenting at conferences, forums and seminars • facilitating workshops and lecturing on postgraduate and pharmaceutical training courses • serving on a PIPA Committee or Working Party, a trade association working party or on an MHRAindustry liaison group or project.

Honorary membership is by nomination only and is awarded to individuals in recognition of their exceptional service to PIPA. The membership levels are awarded as a reflection of an individual’s professional development and experience – but it doesn’t affect what members can access via the website.

PIPA’s intention is that the CPD requirements complement what an individual is currently doing. CPD points are accrued over a rolling two-year period and activities considered to contribute to CPD for PIPA membership include: • postgraduate studies • training courses • conferences and workshops • authoring articles, book chapters and monographs 39

Continuing Professional Development Points Scheme Activity

Points awarded

Limit

Participation in career development and refresher training courses, workshops, forums and conferences including post graduate courses / modules.

1 per hour

Max 8 points per day

Presenting at external training courses, workshops, forums and conferences.

2 per hour of presenting

Max 12 points per day

Facilitation or chairing at workshops, forums or training courses.

1 per hour

Max 8 points per day

Authorship of PIPELINE article

2 per article

–

Authorship of books, chapters or monographs.

20 per book, 10 per chapter, 5 per monograph

–

Mentoring or coaching others.

1 per hour

Max 5 points per 2 years

Active involvement in a Regulatory Authority inspection.

1 per hour

Max 10 points per 2 years

Actively serving on the committee of a recognised industry body e.g. PIPA.

15 per full year

–

Actively serving within a MI / PV related body including PIPA working party, trade association working party.

8 per full year

–

Lecturing at post-graduate courses (by non-academic staff and when not part of member’s core role).

To achieve and maintain Member or Fellow status of PIPA, you need to demonstrate your commitment to CPD by recording at least 40 PIPA CPD points per rolling 2-year period according to the scheme above.

A minimum of 27 points should be directly related to Medical Information and/or Pharmacovigilance (including process, product, disease, regulations, ABPI Code knowledge). You should try to accrue CPD points through a diverse style of activities across the scheme. PIPA CPD points are not accrued for routine work duties but for activities that challenge and develop the member’s skills and expertise.

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What’s the process for uploading CPD and achieving accreditation?

Each CPD cycle is a two-year period.

Once a member has uploaded the relevant evidence, they can click the ‘request review’ button and their record will be reviewed by one of the PIPA team. If the requirements have been met, they will then be awarded the appropriate level of membership.

For each CPD cycle of two years, members must continue to attain at least 40 CPD points to either maintain their current membership status, or to move up to the next membership level.

If at the end of the next CPD cycle a member hasn’t maintained their CPD record, they will drop down to the basic Associate level of membership.

Adding CPD evidence is easy…. simply click on the ‘Add Activity’ button and fill in the form as shown on the screen.

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Any PIPA courses that you attend are automatically added to your CPD points, and your PIPA certificates can be easily accessed via your account.

If you have any questions, or require any assistance with using the system, please do not hesitate to reach out to us via pipa@pipaonline.org

The CPD points tracker shows you how close you are to obtaining 40 points within any particular CPD cycle.

For further guidance on how to upload activities to the system, please watch: https://vimeo.com/622558029/71617cc1c4

We would very much like to encourage you to take advantage of our new CPD system. It is a convenient way of storing and accessing a permanent record of your CPD in one place, which is particularly useful should you wish to move companies. You can also download a report of your CPD, and all of the associated documents should you require it, at any time.

In addition to the convenience of the system, however, is the recognition of your professional achievements.

The use of postnominals can help promote awareness of your expertise to your colleagues as well as helping to demonstrate the skills and expertise of pharmacovigilance and medical information professionals to the wider industry.

Anne Turnbull Operations Manager PIPA

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PRESIDENT’S REPORT

By Tom Nichols

As I write this from my office in Camden, it’s a joy to be out and about again. It’s one thing to enjoy a bit of working from home on your own terms but, after 18 months of imposed solitary confinement, the novelty was beginning to wear off. For me, we’re at the perfect level of hustle and bustle. Enough people around to feel like normality is returning, but not so many I have to queue for my lunchtime burrito.

It’s also strange to think that the majority of people you speak to will now actually understand what our jobs entail. It’s been such a year for the profile of pharmacovigilance and medical information, even my wife can now confidently trot off what PV involves! I mentioned in my first President’s Report that I hoped for a new era of public trust. I don’t think we’re there yet, but greater coverage of the work being done to identify, mitigate and communicate risks can only be a good thing. Yes, some people have been shocked to discover that any drug they take has side effects but, by and large, having faces to put to the previously hidden worlds of MI and PV has started to break down the public image of the pharmaceutical industry as being either lab or marketing based. It’s not ideal to have misunderstood Eudravigilance data quoted to me by people who didn’t know it existed 6 months ago, but even that should be seen in a positive light. Six months ago, people didn’t know data was available and how it was used. Now we are in a position to educate and reassure people that there are experts looking at this data. There will always be people who think they can eyeball something and spot things that experts have somehow missed but, overall, it’s massively beneficial for transparency and trust.

the ‘Effective CAPA and Deviation Management’ and ‘Affiliate Management in PV’ courses taking place, both as virtual events. While the move to online has been a great success for most of our courses, there are some we have found are much better suited to real life attendance. The ability to assess the best method of delivery for each of our courses will really strengthen our offerings in the future and ensure the maximum benefit to the membership. Please do have a look at our training courses on the PIPA website – all of which are CPD accredited in line with our new CPD system.

Once again, I want to pay tribute to both the hard work of the whole PIPA team and the engagement of the membership that has allowed us to successfully complete two years of virtual conferences and the addition of the Global Forum into the mix! Even so, I am delighted that we will be back to holding our face-to-face conference in 2022. PIPA conference has always felt less transactional than others, so it will be a joy to get properly reacquainted with old friends and meet some new ones! We already have some great speakers and sessions confirmed, so keep an eye out for announcements as they come. The PIPA Awards are also entering their 4th year and we look forward to seeing more of the fantastic people we have working in the industry recognised for their achievements.

Tom Nichols

We are also now able to start rolling-out more in-person training courses, with the ‘How to Interpret Clinical Data’ making a welcome return to our curriculum in January. Also in the first few months of 2022 we have

PIPA President

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PIPA COMMITTEE 2020 Who are we?

The PIPA committee is the backbone of the association; and this page features all the current contact details. The Committee is supported by 3 part-time contractors, whose details are also included on this page.

Tom Nichols

Janine Gavin-Poulter Vice President; Code Compliance Collaborative Pharma Ltd.

President Drive Phase PV

Email: vicepresident@pipaonline.org; code@pipaonline.org

president@pipaonline.org; Role: Leadership – strategy & committee / KOL liaison / PIPA representation

Role: Correspondence / Membership matters / Constitution compliance / AGM leadership / Consultation responses / Assisting with organisation of PIPA Code & Compliance Forums

Tracy Crooks

Anne Lloyd

Treasurer Reckitt Benckiser

PV Compliance; Conference Co-organiser; CPD lead Ethypharm UK & Martindale Pharma

treasurer@pipaonline.org

pv-liaison@pipaonline.org; conference@pipaonline.org

Role: Financial lead / Audit & compliance / Invoice payment

Assisting the PIPA membership with ensuring their PV compliance. Assisting with PIPA Conference preparation and delivery. Updating and maintaining a CPD programme relevant to the membership.

Pooja Shah

Dora Amene PV Compliance; PIPELINE Co-Editor TMC Pharma

PIPELINE Co-Editor; Conference Co-organiser Richmond Pharmacology

pv-liaison@pipaonline.org journaleditor@pipaonline.org

journaleditor@pipaonline.org conference@pipaonline.org

Role: Assisting the PIPA membership with ensuring their PV compliance. Preparation and proof-reading of PIPA’s journal, PIPELINE.

Role: Preparation and proof-reading of PIPA’s journal, PIPELINE. Assisting with PIPA Conference preparation and delivery.

Charlotte Mason

Sinem Castro

Medical Information Workstream Jazz Pharmaceuticals

Medical Information Workstream Springer Healthcare

medinfo@pipaonline.org

E-mail: medinfo@pipaonline.org

Role: Assisting the PIPA membership with ensuring excellence in MI.

Role: Assisting the PIPA membership with ensuring excellence in MI.

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Chris Isaacs

Emma Boulton

PV Compliance Novartis

PV Compliance; CPD; Training Workstream Co-Chair Napp Pharmaceuticals Ltd

E-mail: pv-liaison@pipaonline.org;

pv-liaison@pipaonline.org

Role: Assisting the PIPA membership with ensuring their PV compliance.

Role: Assisting the PIPA membership with ensuring their PV compliance. Updating and maintaining a CPD programme relevant to the membership.

Sanjay Motivaras

Stephanie Bettesworth

Communications & Profile Audit PV Ltd

Communications & Profile; PV Compliance Novo Nordisk

E-mail: internet@pipaonline.org

internet@pipaonline.org pv-liaison@pipaonline.org

Role: Raising awareness and engagement within & beyond PIPA.

Role: Raising awareness and engagement within & beyond PIPA. Assisting the PIPA membership with ensuring their PV compliance.

Sharon Braithwaite

Mehrnoosh Ensan

Membership and Events Co-ordinator Contractor PO Box 254, Haslemere, Surrey, GU27 9AF Tel: 07340 519234

Medical Information Workstream; Training Workstream Co-Chair Biogen

medinfo@pipaonline.org training@pipaonline.org

sharon.braithwaite@pipaonline.o

Role: Assisting the PIPA membership with ensuring excellence in MI. Co-ordinating training courses for the PIPA membership.

Sarah Anthony

Anne Turnbull

Administrative and Treasurer’s Support Contractor PO Box 254, Haslemere, Surrey, GU27 9AF

Operations Manager Contractor PO Box 254, Haslemere, Surrey, GU27 9AF

sarah.anthony@pipaonline.org

Tel: 07904 164812

anne.turnbull@pipaonline.org

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TOOLS FOR ADVERSE REACTION ASSESSMENT

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TARA PV was designed by a team of pharmacovigilance professionals who saw the benefits in a user-driven approach to processing and storing drug, device and vaccine adverse events in a secure safety database.

WHO IS IT FOR? – – – –

Accreditations:

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