PIPELINE_67

November 23 The Journal of the Pharmaceutical & Pharmacovigilance Association

Business Continuity Plan Report

The Windsor Framework Guidance

PMCPA Social Media in Practice

£12.00 or Free for Members 771478 327005 65

Issue 67

Template Resource

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PIPELINE

Issue 65

CONTENTS 03 04 07 08 16 20 26 28 31 36 39 40

Letter from the editors

By Mehrnoosh Ensan-Theodorou, PIPELINE Co-Editor

2023 Salary Report: Clinical Research and Medical Affairs

By Julia Day, Client Partner, CK Group

5 step guide to using pharma MI services

By PIPA and UKMi

Read

PIPELINE Online: pipaonline.org/ pipa-journal/

Business Continuity Plan template

By PIPA The Windsor Framework – implications for pharmacovigilance

By John Barber, Plain Pharma Consulting Ltd

MHRA - Government response to consultation on legislative proposals for clinical trials

By Stephanie Bettesworth, Safety and Medical Information Manager, Novo Nordisk

Managing Common Misconceptions About Copyright in Medical Communications

By Erin E. Callahan, Senior Director, Information & Content Solutions, Copyright Clearance Center Pharmacovigilance Challenges during Mergers & Acquisitions

by Miranda Malanga, External Vigilance Engagement, Transition Manager, Novartis UK

PMCPA Social Media Guidance 2023 in practice

By Daniel Sherry, Chief Consultant, RedefineCompliance Ltd.

Leading the way for the next generation of digital medicines information: The new version of emc launches

By John Moreland, Product Manager, Datapharm

Vice-Presidents Report

By Chris Isaacs, PIPA Vice-President

Meet the PIPA Committee 2023

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: Dora Amene

LETTER FROM THE EDITORS We are pleased to welcome you to the 67th issue of PIPELINE and the final edition of PIPELINE for 2023.

In this edition of PIPELINE, we have several topical articles from the medical information and pharmacovigilance world, and we are also happy to present the results of the 2023 Salary Report for Clinical Research and Medical Affairs, which was carried out independently by CK Group. A comprehensive review of salaries was carried out across the lifecycle from early clinical development to post-marketing.

An article on common misconceptions regarding Copyright in Medical Communications addresses the risks and confusion that are often associated with the re-use of published materials and aims to provide clarification on this important issue. Mergers and Acquisitions can also be a challenging aspect of working in the pharmaceutical industry and our current edition includes an article on the associated Pharmacovigilance considerations.

In this issue, we are pleased to present an infographic version of the document we produced previously in collaboration with UK Medicines Information (UKMi) to assist pharmacists in their interactions with pharmaceutical medical information departments.

This new document highlights the key points in a visual manner.

At the start of this year, the PMCPA published its first Social Media Guidance, which is a huge step forward in the industry. An overview of this guidance is included in this issue by a compliance expert, as well as an overview article on the new emc website provided by Datapharm.

With Medical Information Departments playing such a vital role in information provision and the handling of safety data, it is important for them to have a Business Continuity Plan (BCP). In this edition, we have a included a template that has been created

by PIPA to help Medical information departments with their creation of BCPs.

Outside of PIPELINE, PIPA has been busy in several activities such as running our training courses, updating our guidance documents in line with industry updates, delivering our regular webinars and working on increasing the impact of CPD offerings.

Finally, we just want to thank our speakers, exhibitors and delegates for their active participation the PIPA 2023 conference. We hope all of you enjoyed it as much as we did and we are very much looking forward to welcoming you to the 2024 annual conference. The programme will be available on the PIPA website in the next few months. To take advantage of a special booking price, why not book your attendance now!

The Windsor Framework is currently an important topic in the area of Pharmacovigilance, as well as the industry as a whole. In this edition, John Barber provides an overview of the implications of the Windsor Framework for Pharmacovigilance departments and discusses what the next steps may be. If you’re interested in this topic, don’t forget we have a round table discussion happening at this year’s conference.

In addition to conference, we invite all of our membership to take advantage of PIPA’s webinars and discussion forums which are opportunities for our members to reach out to each other, exchange ideas and discuss topics of interest.

We have also included a summary article on the government’s response to the recent consultation on legislative proposals for clinical trials.

As always, feedback from the membership is welcomed and we encourage you to interact with us and the wider PIPA membership via our online platforms below: Official PIPA Website: https://www.pipaonline.org/ LinkedIn: https://www.linkedin.com/company/pipa-pharmaceutical-information-andpharmacovigilance-association/ We hope to see you online at one of our events in the near future.

If there is anything you would like to see PIPA get involved with or do, please do get in touch at pipa@pipaonine.org We encourage more members to contribute to PIPELINE and make suggestions on topics for articles. Please contact us at journaleditor@pipaonline.org if you would like to contribute or make suggestions for the next edition.

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Written by Mehrnoosh Ensan-Theodorou PIPELINE Co-Editor

2023 SALARY REPORT: CLINICAL RESEARCH AND MEDICAL AFFAIRS A comprehensive overview of salaries across the lifecycle from early clinical development to post-marketing; assessing contributing factors, benefits and role remits.

the pharmaceutical, biotechnology and associated industries in the UK. From this, we received an excellent number of responses, with over 2500 very credible professionals completing the survey (we took the time to check the data of each respondent to confirm it was indeed true).

We are pleased to introduce our 2023 Salary Report where we collated and analysed salary data by functional area from clinical development to medical affairs.

This comprehensive report contains valuable information on the latest salary data and benefits across numerous sectors including Drug Safety and Medical Information which we hope will be of interest to PIPA members.

Whether you’re looking to negotiate your next pay raise, effectively plan your hiring budget, number crunch outsourcing figures or looking at career trajectory, I hope you will find this useful.

Whilst conducting this research, we targeted our networks within

INTRODUCTION We are in the privileged position of having excellent insights into the salaries and benefits in our markets from our roles in recruitment. However, we appreciate that for some businesses in pharmaceuticals and biotechnology, as well as the individuals in these industries, it can be very difficult to find unbiased and UK specific information on salaries and benefits.

The functional areas we targeted were: •

Therefore, we are pleased to be able to provide these insights to this sector. This project has provided some very interesting results and occasionally surprising data that we did not expect.

Thank you to the 2500+ professionals who took the time to complete our survey in detail. Their contribution is greatly appreciated.

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Medical Information, Medical Affairs, Medical Compliance Governance and Ethics

•

Clinical Operations

•

Clinical Development

•

Biometrics

•

Regulatory Affairs

•

Clinical Quality Assurance

•

Drug Safety

There are also certain functional nuances we have looked into, e.g. final signatory / appropriate qualified person (AQP) status in medical affairs, and, where possible, therapy areas and their effects on salaries and different regulatory specialisms.

We endeavoured to look at a number of factors for each functional area covered. We looked at the level of respondents via title and then analysed the responses via (where the data permitted):

•

Salary banding - low, average and high

•

Qualifications held vs average salaries

•

Industry type and the effects on pay

•

•

•

•

Strategic and line management responsibilities – do either or both effect pay and, if so, how?

How geographical remit of a role impacts salaries Benefits being offered at each level (a focus here on car allowances and bonus) Motivations to move roles at each level within each function

Using the data and these factors we were able to draw some very interesting conclusions, confirm existing opinions and disprove others.

We gained some great insights into the salaries and packages offered by different industries for different functional roles and levels within them.

TOP LEVEL INSIGHTS: The salary comparisons covered in this section are as follows: •

•

•

Speciality therapies consistently pay a higher salary with rare and orphan diseases holding a particular premium In some areas, the level of qualification obtained had little impact on salaries - with respondents holding a BSc earning more than those with a PhD…

•

•

For the most part, Pharmaceutical and Biotechnology companies pay higher salaries than CROs, Not for Profits, Consultancies and Medical Device organisations. They also have better benefits Increasing geographical responsibilities (i.e. global vs EU or UK remit) does not always increase salaries In some cases, respondents with line management responsibilities earn less than those who do not manage!

INSIGHTS FROM MEDICAL INFORMATION AND PHARMACOVIGILANCE:

64% OF DRUG

93.33% of Associate Directors and Directors of Drug Safety receive a bonus and 40% of these receive a bonus at 15-25%. Also, 73% of respondents receive a

SAFETY MANAGERS RECEIVE A BONUS OF BETWEEN 10-15%.

CAR ALLOWANCE OF BETWEEN

£7-8K .

However only 33% of those in a CRO receive a bonus compared to 91.67% of those employed by a pharma company.

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The average salary of a Drug Safety Scientist / Senior is

£42,500

WITH AN AVERAGE OF 7 YEARS OF EXPERIENCE.

A Drug Safety Scientist with a UK / Local remit earns slightly more than those with above country level responsibilities.

A Medical Information Manager / Director with an average of 12.44 years’ experience earns on average £86,250 pa and the

A Medical Information Manager / Director with AQP signatory status seems to warrant an increase in salary of

HIGHER END OF THE SCALE IS APPROXIMATELY

20% WHEN

COMPARING TO NON-SIGNATORIES.

£105,000 pa

A GLOBAL REMIT OFFERS A HIGHER SALARY

WORKING WITH SPECIALITY MEDICINES offers the highest salaries for Medical Information Mangers/ Directors.

than an EU or UK remit for a Medical Information / Senior.

A Medical Advisor / Senior Medical Advisor with line management responsibility earns

MYTH BUSTER -

9.2% MORE THAN

Medical Advisor / Senior Medical Advisor roles. Are respondents in a global role because they are nonsignatories? No - 80% of those with global responsibilities are final medical signatories. The remaining 20% held PhDs and were AQPs/Business Signatories.

THOSE WITHOUT.

This is just a small snippet of the findings from the report, if you would like to find out more the report is available to download for free at: https://ckgroup.co.uk/ck-group-2023-salary-survey/

Our hope is that you find this resource very useful and can save it for future reference.

Discussion of findings and industry insights:

Julia Day who authored this survey welcomes the opportunity to speak in more detail around the findings, and limitations of this survey plus share further industry insights. She is also happy to receive feedback to help us shape our next report. Please contact her if you have questions: Jday@ckgroup.co.uk

Written by Julia Day Client Partner, CK Group 6

In the September 2021 edition of PIPELINE, we published a document produced collaboratively with UK Medicines Information (UKMi) entitled ‘How to Use Pharmaceutical Industry Medical Information Services’.

The aim of this document is to assist UKMi Pharmacists with their interactions with pharmaceutical Medical Information departments.

We have now created an infographic version of this document which highlights the key points in a visual and succinct manner.

This document has been shared with UKMi Pharmacists by their executive team.

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BUSINESS CONTINUITY PLAN TEMPLATE

With Medical Information Departments having such a vital role in providing information, as well as receiving and documenting safety data and personal medical histories, it is important that these departments have a Business Continuity Plan (BCP).

BCPs not only provide information for resolutions when something has gone wrong, but they are also a good way of evaluating potential risks, vulnerabilities and weaknesses that could disrupt the department and prevent officers from helping patients and other healthcare professionals, or receiving safety data.

Below is a template created by PIPA to help MI departments with the creation of these BCPs, which should be created and revalidated at least once a year.

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BUSINESS CONTINUITY PLAN MEDICAL INFORMATION [COMPANY NAME] CONTENTS 1.

Aim of the plan 2

2.

Objectives of the plan 2

3.

Notification/Distribution List

2

3.1 Who needs to be informed 2 3.2 Contact details of Staff Involved in BCP Process

3

3.3 Roles of staff in an incident

3

4.

Your Business Priorities: Critical Function Checklist

3

4.1 List the functions carried out by the Medical Information department

3

4.2 Disruption to Business Functions 4 5.

Critical Function Analysis and Recovery Process 4

5.1 Risk Assessment 4 6.

Service Level Agreements (vendors) 6

7.

Emergency Response Checklist 7

8.

BCP DOCUMENT CONTROLS 7

9:

AUTHORISATION

1 BUSINESS CONTINUITY PLAN MEDICAL INFORMATION

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BUSINESS CONTINUITY PLAN MEDICAL INFORMATION [COMPANY NAME] 1.

AIM OF THE PLAN

The aim of this local business continuity plan is to ensure the [COMPANY NAME] Medical Information department is able to continue to deliver essential medical information services in the face of a disruptive incident.

2.

OBJECTIVES OF THE PLAN

The key objectives of the plan are to: •

Provide basic information about the service, including staff and core supplier contact information

•

Provide an overview and prioritisation of essential services delivered by the department to patients and healthcare professionals

•

Outline and analyse known risks to delivery of these services, including reduction of risks where possible

•

Provide a framework for responding to any disruptive incident the department may face

•

Identify some of the key actions staff can take in a disruptive incident.

3.

NOTIFICATION/DISTRIBUTION LIST

3.1

WHO NEEDS TO BE INFORMED

This section outlines who should be informed in the event of an incident. If this is complicated, a cascade diagram (such as the example below) may be appropriate. Contact details should be added to 3.2 rather than in the cascade diagram.

NAME OF STAFF MEMBER WHO DETECTS INCIDENT

NAME OF STAFF MEMBER WHO SHOULD BE INFORMED

NAME OF STAFF MEMBER WHO SHOULD BE INFORMED

2 BUSINESS CONTINUITY PLAN MEDICAL INFORMATION

NAME OF STAFF MEMBER WHO SHOULD BE INFORMED

BUSINESS CONTINUITY PLAN MEDICAL INFORMATION [COMPANY NAME] 3.2

CONTACT DETAILS OF STAFF INVOLVED IN BCP PROCESS

These should not be in the form of a cascade diagram. Up-to-date contact details should be added to a table such as the below.

NAME

3.3

ROLE

TEL

ROLES OF STAFF IN AN INCIDENT

This section should detail the roles of each staff member when notified of an incident. This includes who should be responsible for recovery after the incident, and/or whether anyone else needs to be informed of the incident.

POSITION

ROLE IN AN INCIDENT

4.

YOUR BUSINESS PRIORITIES: CRITICAL FUNCTION CHECKLIST

4.1

LIST OF FUNCTIONS UNDERTAKEN BY THE MEDICAL INFORMATION DEPARTMENT

Indicate if the failure of the function would impact any of the wider business.

The risk assessment for each function is listed in section 5.1, and this table is a summary of those functions.

Use the following classifications to ascertain priority.

Critical – losing this function is critical and there is a high impact on the wider business. For example, patient safety issues.

The function needs to be recovered in as short a time as possible.

Important – there would be a medium impact on the wider business, and the function needs to be recovered quickly, but this is not a critical function.

Needed – no impact, and the function needs to be recovered when possible.

3 BUSINESS CONTINUITY PLAN MEDICAL INFORMATION

BUSINESS CONTINUITY PLAN MEDICAL INFORMATION [COMPANY NAME] 4.1

LIST OF FUNCTIONS UNDERTAKEN BY THE MEDICAL INFORMATION DEPARTMENT (CONTINUED)

REFERENCE

PRIORITY

FUNCTION

TIMEFRAME

Number of function, 1,2,3,4 etc

Critical/important/needed

[Name of function or activity e.g. Receiving queries]

[Recovery timeframe e.g. restore within 2 hours]

1 2 3 4 5

4.2

DISRUPTION TO BUSINESS FUNCTIONS

This section asks you to describe the impact of not delivering each of the business functions you identified in section 4.1.

FUNCTION NUMBER

What is the maximum amount of time that this function could remain undelivered?

Impact over time: Indicate where and when you consider serious impact will occur VERY HIGH 0-6 HOURS

6-12 HOURS

HIGH

MEDIUM

LOW

VERY LOW

12-24 HOURS

1-3 DAYS

4-7 DAYS

2-6 WEEKS

Comments/justification (where an impact over time has been identified)

5.

CRITICAL FUNCTION ANALYSIS AND RECOVERY PROCESS

5.1

RISK ASSESSMENT

IMPACT

Use the below table to ascertain risk.

Catastrophic (5)

LOW

HIGH

VERY HIGH

VERY HIGH

VERY HIGH

Significant (4)

LOW

HIGH

VERY HIGH

VERY HIGH

VERY HIGH

Moderate (3)

LOW

LOW

HIGH

HIGH

HIGH

Minor (2)

LOW

LOW

MEDIUM

MEDIUM

MEDIUM

Insignificant (1)

LOW

LOW

LOW

LOW

LOW

Negligible (1)

Rare (2)

Unlikely (3)

Possible (4)

Probable (5)

LIKELIHOOD 4 BUSINESS CONTINUITY PLAN MEDICAL INFORMATION

BUSINESS CONTINUITY PLAN MEDICAL INFORMATION [COMPANY NAME] Each identified function in 4.1 should have its own table.

FUNCTION 1

REFERENCE:

CRITICAL FUNCTION:

PRIORITY:

Responsibility:

Name of the person overseeing this activity

Potential impact on organisation if interrupted:

Examples are patient safety, legal implications, financial implications etc

Likelihood of interruption to organisation:

Use table above to classify risk of disruption

Recovery timeframe:

(how quickly must this function be recovered to avoid lasting damage)

RESOURCES REQUIRED FOR RECOVERY: Data / IT systems

What needs to happen to get IT systems back up and running in the event of an issue, and who is responsible? For example- are IT required to help facilitate recovery of the system?

Premises

Can colleagues work from home in the event of an issue?

Communications

Who needs to be contacted in the event of an issue?

Equipment

What equipment (if any) is needed to resolve the issue?

FUNCTION 2

REFERENCE:

CRITICAL FUNCTION:

PRIORITY:

Responsibility:

Name of the person overseeing this activity

Potential impact on organisation if interrupted:

Examples are patient safety, legal implications, financial implications etc

Likelihood of interruption to organisation:

Use table above to classify risk of disruption

Recovery timeframe:

(how quickly must this function be recovered to avoid lasting damage)

RESOURCES REQUIRED FOR RECOVERY: Data / IT systems

What needs to happen to get IT systems back up and running in the event of an issue, and who is responsible? For example- are IT required to help facilitate recovery of the system?

Premises

Can colleagues work from home in the event of an issue?

Communications

Who needs to be contacted in the event of an issue?

Equipment

What equipment (if any) is needed to resolve the issue?

5 BUSINESS CONTINUITY PLAN MEDICAL INFORMATION

BUSINESS CONTINUITY PLAN MEDICAL INFORMATION [COMPANY NAME]

FUNCTION 3

REFERENCE:

CRITICAL FUNCTION:

PRIORITY:

Responsibility:

Name of the person overseeing this activity

Potential impact on organisation if interrupted:

Examples are patient safety, legal implications, financial implications etc

Likelihood of interruption to organisation:

Use table above to classify risk of disruption

Recovery timeframe:

(how quickly must this function be recovered to avoid lasting damage)

RESOURCES REQUIRED FOR RECOVERY: Data / IT systems

What needs to happen to get IT systems back up and running in the event of an issue, and who is responsible? For example- are IT required to help facilitate recovery of the system?

Premises

Can colleagues work from home in the event of an issue?

Communications

Who needs to be contacted in the event of an issue?

Equipment

What equipment (if any) is needed to resolve the issue?

*This table may be copied for further critical functions and activities*

6.

SERVICE LEVEL AGREEMENTS (VENDORS)

Are there any contractual arrangements i.e. SLA requirements to deliver the functions of the department?

Details of these should be added below.

COMPANY NAME (WHO THE SLA IS WITH, OR VENDOR)

WHICH FUNCTION THE VENDOR IS RESPONSIBLE FOR PROVIDING (IN 5.1)

What is the function, for example does the vendor provide medical Information or translation services?

6 BUSINESS CONTINUITY PLAN MEDICAL INFORMATION

DAY AND TIME DUE

IMPACT AND PENALTY IF NOT DELIVERED

How often does the vendor provide the service?

(detail level of impact + rationale, such as noncompliance with processing of adverse events within relevant timelines or financial implications)

BUSINESS CONTINUITY PLAN MEDICAL INFORMATION [COMPANY NAME] 7.

EMERGENCY RESPONSE CHECKLIST

This page should be used as a checklist during the emergency.

TASK:

COMPLETED (DATE, TIME)

ACTIONS WITHIN 24 HOURS: Start of log of actions undertaken Contact those in section 3.1 (or start the cascade diagram) Identify and quantify any damage to the organisation, including staff, premises, equipment, data, records, etc.

Assess the key priorities for the remainder of the working day and take relevant action.

Consider sending staff home, to recovery site etc Identify which critical functions have been disrupted (use section 4.1) DAILY ACTIONS DURING THE RECOVERY PROCESS: Daily reports received from recovery team (those responsible for recovering the function, such as the IT team) Provide information to: • Staff • Vendors (if applicable) • Those in the cascade diagram (if applicable) FOLLOWING THE RECOVERY PROCESS: Arrange a debrief of all staff and identify any additional staff welfare needs Use information gained from the debrief to review and update this business continuity management plan

8.

BCP DOCUMENT CONTROLS

DATE PUBLISHED VERSION NUMBER & TYPE (E.G. DRAFT, FINAL ETC.) DATE OF BCP REVIEW DUE

9.

AUTHORISATION

SIGNATURE OF DEPARTMENT HEAD:

7 BUSINESS CONTINUITY PLAN MEDICAL INFORMATION

Date:

Name:

THE WINDSOR FRAMEWORK –

IMPLICATIONS FOR PHARMACOVIGILANCE INTRODUCTION Although we have been told that Brexit is done, the unique situation of Northern Ireland has not been resolved despite the implementation of The Northern Ireland Protocol.

This failed to address the Northern Ireland trilemma that cannot resolve the conflicting requirements of the Good Friday/Belfast Agreement that there should be no hard border on the island of Ireland, the Brexit agreement that required the UK to no longer be part of the single market and the customs union, and the Union of the United Kingdom that requires no border between Northern Ireland and the rest of the UK (see Figure 1).

NO HARD BORDER ON THE ISLAND OF IRELAND

BORDER IN THE IRISH SEA, RISK TO THE UNION OF THE UK

UK TO REMAIN IN THE SINGLE MARKET & CUSTOMS UNION, REVERSE BREXIT

LEAVE SINGLE MARKET & CUSTOMS UNION

NO BORDER IN THE IRISH SEA HARD BORDER ON THE ISLAND OF IRELAND, BREACH OF GOOD FRIDAY/ BELFAST AGREEMENT

Figure 1: The Northern Ireland Trilemma In recognition of the problems that the Brexit agreement and the Northern Ireland Protocol were causing both politically and economically in Northern Ireland, the UK Government and the European Commission developed a joint proposal known as The Windsor Framework1. This was released with great publicity on the 23rd February 2023. In essence, the Framework recognises that Northern Ireland is politically and economically integrated into the UK as well as recognising the requirements of the 1998 Good Friday/Belfast Agreement that there should be no hard border on the island of Ireland.

Under current arrangements, medicines regulations in Northern Ireland must comply with EU regulations. These requirements have been reviewed previously and will not be discussed in detail now. As a consequence of having to align with EU regulations, it has been reported that it has impacted the registration of medicines with an applicable product licence (PL) for Northern Ireland, either as a full UK PL or a PLNI2.

A number of generic Marketing Authorisation Holders (MAHs), for example, have gone down the route of only obtaining PLGBs as this avoids having to implement packaging and controls that conform to the requirements of the Falsified Medicines Directive. The Framework, when implemented, should resolve this issue.

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WHAT DOES IT SAY ABOUT PHARMACOVIGILANCE? Clauses 34 to 37 of the Framework refer specifically to medicines (see text box 1). However, there is no explicit reference to pharmacovigilance. What the Framework could mean for pharmacovigilance must therefore be inferred from what is stated in these clauses, specifically what is stated in Clause 36 (see highlighted text in text box 2).

information in the Article 57 database, where the MAH has a valid authorisation in Northern Ireland, will no longer be required • Non-serious adverse event reports from Northern Ireland

will no longer be required to be submitted to EudraVigilance

This Clause appears to remove any role of the EMA regarding medicines regulation in Northern Ireland with the MHRA having a sole and sovereign role for the whole of the UK. The implications for pharmacovigilance appear to be quite significant and may include:

• Northern Ireland will no longer be a Concerned Member

State in Mutual Recognition or Decentralised Procedures or included in a Centrally Authorised Procedure. The MHRA will therefore no longer receive assessment reports associated with these procedures. Will MAHs be requested to share these with the MHRA?

• UK QPPV must be based in the UK with the role of the UK

National Contact Person for Pharmacovigilance to be obsolete

• PSURs submitted to the EMA for single assessment will

also have to be submitted to the MHRA. Will MAHs be requested to submit PSUR single assessment reports to the MHRA?

• No role for the EU QPPV in the oversight of the UK

pharmacovigilance system

• Revision of the MHRA’s Guidance Note on exceptions and

modifications to GVP.

• Registration of the UK QPPV, UK PSMF and UK product

“If all goes to plan, The Windsor Framework will come into effect on 1st January 2025”

A WORD OF CAUTION Whilst it appears that the promise of Brexit that the UK will be free from European regulatory control is about to be realised, the scope for the UK to significantly diverge from these controls is constrained.

carve it out of having to abide by the proposed new European requirements. However, there is a sting in the tail. Article 210 of the proposed Directive gives the European Commission a role of monitoring the medicines regulatory environment in the UK. If the European Commission perceives that changes to regulations in the UK are no longer essentially equivalent to the protections for public health afforded by the European Directive, then regulatory actions can be taken by the European Commission which can include suspension of the derogations for Northern Ireland.

Shortly after The Windsor Framework was released, the European Commission released proposals for a new Regulation3 and a new Directive4 for medicinal products. The proposed new EU Directive on medicinal products includes derogations in relation to Northern Ireland that effectively

17

WHAT NEXT? Hopefully, we will not be faced with the last-minute publication of guidance that occurred just prior to EU Exit Day that resulted from the political brinkmanship. MAHs should have adequate time to revise their systems and processes to be compliant with the potential new requirements.

If all goes to plan, The Windsor Framework will come into effect on 1st January 2025. Before then, legislation will have to be enacted by the UK Government to implement the Framework. New or revised guidance will also need to be developed by the MHRA and they have committed to engagement with stakeholders as part of this process. This should include consultation with the UK trade associations and hopefully PIPA will have a seat at these discussions. It is not clear when this exercise will start but it is hoped that it will begin no later than autumn of this year.

REFERENCES

01 02 03

04

A general election is due before the end of 2024. At the time of going to press, it looks like there will be a radical change of government. Whether this has an impact upon the enactment of the required legislative changes cannot be predicted but is considered unlikely due to the urgent need to resolve the issues relating to Northern Ireland.

that the overwhelming flow of medicines to Northern Ireland is from Great Britain,

The Windsor Framework: A New Way Forward.

HM Government. 27 February 2023. https://assets.publishing.service.gov.uk/government/ uploads/system/uploads/attachment_data/ file/1138989/The_Windsor_Framework_a_new_way_ forward.pdf

with medicines provided for the UK market as a whole.

35. The EU made a series of changes to its rules last year to address some of these issues, addressing regulatory requirements which prevented medicines flows and supporting the MHRA’s continued ability to authorise generic drugs under a single licence for the whole United Kingdom. This, combined with the UK’s own Northern Ireland Medicines Authorisation Route (NIMAR), has ensured

Health and Brexit: six years on. Nuffield Trust.

December 2022. https://www.nuffieldtrust.org.uk/sites/default/ files/2022-12/1671199514-health-and-brexit-web.pdf

that medicines have continued to flow uninterrupted into Northern Ireland. But these arrangements were not a complete solution for the long-term and did not address the EMA’s role in licensing novel medicines, leaving Northern Ireland exposed to divergence as UK and EU rules changed into the future.

Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006. 2023/0131 (COD). 26 April 2023. https://eur-lex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:52023PC0193

This uncertainty, as well as the requirement for Northern Ireland drugs to meet various EU labelling requirements, risked discontinuations if firms were unwilling to maintain two sets of labels and packs for Great Britain and Northern Ireland. This was not a sustainable way forward, and has been addressed by this deal.

36. Under the agreement, we have listened to the needs of industry and the healthcare sector and secured an unprecedented settlement that provides a comprehensive carve-out from EU rules: fully safeguarding the supply of medicines from Great Britain into Northern Ireland, and once again asserting the primacy of UK regulation. As a result, it will be for the MHRA to approve all drugs for the whole UK market. This will enable all types of medicines to be supplied in single packs, within UK supply chains, with a single licence for the

Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC. 2023/0132 (COD). 26 April 2023. https://eur-lex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:52023PC0192

whole UK. This will provide a long-term, durable basis for medicines supplies into Northern Ireland.

•

Specifically, the whole of the Falsified Medicines Directive has been disapplied for medicines supplied to Northern Ireland, ending the unnecessary situation in which - even with grace periods - wholesalers and pharmacies in Northern Ireland were expected to keep barcode scanners to check individual labels.

•

And for the provision of innovative drugs to patients, Northern Ireland will be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency removed from having any role.

Text box 1: Clauses 34 to 37 from The Windsor Framework

•

This responds to the overwhelming calls from industry for stability and certainty, and can give reassurance to patients and clinicians in Northern Ireland well into the future.

Medicines 34. The original Protocol applied all EU rules and authorisation requirements for medicines, notwithstanding that medicine supply is an essential state function.

37. At the same time, the agreement safeguards frictionless access to the EU

This meant that for novel medicines, including innovative cancer drugs, it was

market for world-leading Northern Ireland pharmaceutical and medical technology

the European Medicines Agency (EMA), not the UK’s Medicines and Healthcare

firms. This pragmatic dual-regulatory system protects business, patients and

products Regulatory Agency (MHRA), which approved medicines for the

healthcare services, and reflects that it is an essential state function to maintain and

Northern Ireland market. This failed to recognise or accommodate for the fact

oversee the supply of medicines within the whole United Kingdom.

18

Text box 2: Clause 36 from The Windsor Framework

•

Specifically, the whole of the Falsified Medicines Directive has been disapplied for medicines supplied to Northern Ireland, ending the unnecessary situation in which - even with grace periods - wholesalers and pharmacies in Northern

36.Under the agreement, we have listened to the needs of industry and the

Ireland were expected to keep barcode scanners to check individual labels.

healthcare sector and secured an unprecedented settlement that provides a comprehensive carve-out from EU rules: fully safeguarding the supply of

•

medicines from Great Britain into Northern Ireland, and once again asserting

And for the provision of innovative drugs to patients, Northern Ireland will be reintegrated back into a UK-only regulatory environment, with the

the primacy of UK regulation. As a result, it will be for the MHRA to approve all

European Medicines Agency removed from having any role.

drugs for the whole UK market. This will enable all types of medicines to be supplied

•

This responds to the overwhelming calls from industry for stability and certainty,

in single packs, within UK supply chains, with a single licence for the whole UK. This

and can give reassurance to patients and clinicians in Northern Ireland well into

will provide a long-term, durable basis for medicines supplies into Northern Ireland.

the future.

Text box 3: Extract from the proposed new EU Directive

of, inter alia, inspections and audits of marketing authorisation holders, manufacturing authorisation holders and wholesale distributors located in their

Article 210

territories, and on-the-spot checks at their premises regarding the exercise of

Regulatory functions carried out in the United Kingdom

the regulatory functions referred to in point (a).

1. The Commission shall continuously monitor developments in the United

2. Where the Commission finds that the level of protection of public health

Kingdom that could affect the level of protection regarding the regulatory

ensured by the United Kingdom through rules governing the production,

functions referred to in Article 99(4), Article 151(3), Article 211, paragraphs 1,

distribution and use of medicinal products as well as the effective enforcement

2, 5 and 6, Article 209, paragraphs 6 and 7, that are carried out in parts of the

of those rules is no longer essentially equivalent to that guaranteed within the

United Kingdom other than Northern Ireland taking into account, in particular, the

Union, or where sufficient information is not available to the Commission to

following elements:

enable it to establish whether an essentially equivalent level of protection of public health is ensured by the United Kingdom, the Commission shall inform

(a) the rules governing the granting of marketing authorisations, the obligations of

the United Kingdom through a written notification of that finding and of the

the marketing authorisation holder, the granting of manufacturing authorisations,

detailed reasons therefor.

the obligations of the manufacturing authorisation holder, the qualified persons and their obligations, quality control testing, batch release and pharmacovigilance

For a period of six months following the written notification made pursuant

as laid down in United Kingdom law;

to the first subparagraph, the Commission shall enter into consultations with the United Kingdom with a view to remedying the situation giving rise to that

(b) whether the competent authorities of the United Kingdom ensure the effective

written notification. In justified cases, the Commission may extend that period

enforcement within their territory of the rules referred to in point (a), by means

by three months.

Written by John Barber, Plain Pharma Consulting Ltd

19

MHRA - GOVERNMENT

RESPONSE TO CONSULTATION ON LEGISLATIVE PROPOSALS FOR CLINICAL TRIALS SUMMARY OF CONSULTATION OUTCOMES On 21 March 2023, the UK Government published its response to the consultation on legislative reform proposals for clinical trials that took place from January to March 2022.

88%

Individual responses

Organisational responses

Responses were received from across the UK and internationally, including from European countries, the USA, Australia, Canada, New Zealand, South Africa, Japan and India, and from global organisations.

12%

Responses from 2138 respondents were analysed (88% from individuals and 12% from organisations). Individual responders included members of the public, patients, carers, researchers, and health care professionals. Organisational responses came from industry trade associations, academic institutions, individual pharmaceutical companies, not for profit organisations involved in drug development, patient advocacy groups, regulatory/ professional representation bodies and health delivery organisations.

There was strong support for the proposal to update and improve the legislation for clinical trials.

“The new framework is the biggest overhaul in UK Clinical trials regulations in over 20 years”

The new framework is the biggest overhaul in UK Clinical trials regulations in over 20 years and the proposed reform sets out to deliver “a more agile and flexible UK regulatory framework”, that will “remove obstacles to innovation” and “streamline” regulations as part of the Government’s ambition to create a more appealing regulatory environment for life sciences innovation in the UK. The new legislation promises to: • Ensure patients and their safety are at the focus of all clinical

trials and bring the benefits of clinical trials to everyone

• Create a proportionate and flexible regulatory environment • Cement the UK as a destination for international trials • Provide a framework that is streamlined, agile and responsive

to innovation.

20

PROPOSALS NOT TAKEN FORWARD different ages and population groups, depending on the condition being addressed. Although this would give greater ability to assess efficacy and risk specifically in those patient populations responses suggested this was better approached through guidance rather than new legislative requirements, with greater flexibility to update and adapt with new knowledge and experience.

Following the consultation, there are four proposals that the MHRA are not taking forward: Firstly, enabling regulators to take into account previous information of non-compliance when considering a new clinical trial application.

Comments raised important unintended consequences such as a reduction in trials being conducted in the UK and increased reluctance to adopt proportionate approaches.

Lastly, the MHRA will also be producing guidance on patient and public involvement, highlighting best practice rather than legislating for this. There was clear understanding that public involvement can add enormous value to improve the quality of research and ensure that it is most relevant to those the study is aiming to benefit. However, responses also raised clear concerns that introducing a new legal requirement at this time could ultimately act as a disincentive, leading to trial sponsors choosing not to run their trial in the UK.

Secondly, the collection of data on unlicensed medicines due to the Early Access to Medicines Scheme, which already delivers on the intent of this proposal.

Thirdly, plans to legislate to ensure diversity throughout the trial population, for example ensuring sex balance, participants of

UPCOMING CHANGES The draft legislation is not yet available. However, the main proposals with which the Government intends to move forward are summarised below under 9 subcategories.

01 RESEARCH TRANSPARENCY The MHRA consulted on three proposals to increase transparency of trials: • To register a trial prior to its start The MHRA will introduce a legislative requirement to register a trial in a World Health Organization compliant public register unless a deferral is agreed by or on behalf of the Research Ethics Committee.

•

To publish a summary of results within 12 months of the end of the trial (unless a deferral has been agreed).

•

To share trial findings with participants in a suitable format (or explain why this is not possible).

21

02 CLINICAL TRIALS APPROVAL PROCESS the process of requesting this information.

The MHRA consulted on several proposed changes to update the process for approval of clinical trial applications and to simplify and streamline processes.

• For a trial sponsor having sight of Requests for Further Information (RFI) when they are ready, rather than issued when the final part of the assessment is complete.

Combined Regulatory and Research Ethics Approval • For a combined MHRA and ethics review of a maximum 30 days in general, with maximum 10 days for a final decision following receipt of any Request for Further Information responses.

The MHRA will consider whether the ability to sight sponsors on RFIs needs to be actively included in legislation or if the best course of action is simply ensuring legislation does not block this ability.

• For a 60-day timeline for Sponsors to respond to any requests for

further information.

• For the ability to receive an RFI during the review of a substantial amendment.

• For the ability for the regulators to extend the timeframe for

The MHRA will include clear and competitive timelines for response and final decision. The legislation will also allow an outright rejection of an unacceptable amendment without an RFI step.

medicinal products or trials where the risks involved may be greater so that independent expert advice can be sought.

• For a clinical trial approval to lapse after a specified time limit if no

participants have been recruited. However, it was noted that there should be exceptions for certain trials and a clear process for how exemptions to the lapse will be requested and reviewed.

Notification Scheme for Low Intervention Trials This consultation proposed introducing a notification scheme for Low Interventional trials into legislation. Low Intervention trials are clinical trials where the risk is similar to that of standard medical care and a clinical trial can be approved without the need for a full regulatory assessment.

When asked whether the detail currently outlined in schedule 3, which sets out the documents that accompany an application, would be better placed in guidance or legislation, the feedback was mixed. However, the majority were in favour of the detail being in guidance and the MHRA plan to take this forward. Responses highlighted guidance will be important to ensure appropriate interpretation of the legislation.

• To introduce the concept of a notification scheme into legislation.

The MHRA confirmed that an appropriate level of oversight for these trials will be maintained through Research Ethics Committees. Any trials identified as not being eligible for the Notification Scheme will be referred to the standard MHRA authorisation process.

Requests for Further Information (RFI) This consultation made proposals to introduce greater flexibility to the formal communication between applicants and regulators during

03 RESEARCH ETHICS The consultation proposed to update requirements for the make-up and minimum number of members of Research Ethics Committees (RECs) and remove restrictive and granular requirements such as for premises and facilities and refer to guidance to allow for greater agility in decision making.

•

To include a cross-sectional make-up of members as outlined in the consultation document.

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04 INFORMED CONSENT IN CLUSTER TRIALS Cluster trials are a way to perform large-scale randomised controlled trials to compare different available treatments and observe which is the most effective. Cluster trials are conducted on existing approved medicines, where randomisation to a certain treatment is pre-determined by location.

the majority supported the proposal. Concerns surrounded that with flexible consent provisions, participants may be unaware of what is being investigated and what alternative options are available. Guidance will be developed alongside the legislation to support flexibility on consent provisions in trials that are considered to have a lower risk.

• For flexibility on consent provisions where the trial is

considered to have lower risk.

• For cluster trials comparing existing treatments to use a

simplified means of seeking agreement from participants.

The consultation proposed to simplify the way that informed consent can be obtained for cluster trials to promote greater use of these kinds of trials. The proposal was that legislation should enable flexibility on consent provisions, ensuring consent is sought to the correct standards, but more proportionate approaches to seeking consent where the risk is lower are available. There were mixed responses however

Such trials present little or no additional risk to the participant as they would be randomised to receive a standard treatment routinely prescribed for their condition. The patient would not need to do anything other than take the treatment as normal and the data needed for the trial would be extracted from their medical notes.

05 SAFETY REPORTING There was a small majority and therefore the proposal will proceed. However, aggregate reporting will not be mandatory and will only be accepted if pre-specified criteria are met. Clear guidance will be given.

The consultation proposed updates to the pharmacovigilance aspects of clinical trials, aimed at reducing administrative burden while maintaining the highest standards of participant safety.

• To remove the requirement for individual SUSARs to be

• To remove the requirement to include listings of serious adverse events and serious adverse reactions in annual safety reports and instead include an appropriate discussion of signals/risks associated with the use of the medicinal product as well as proposed mitigation actions.

reported to all investigators.

Sponsors of clinical trials need to identify Suspected Unexpected Serious Adverse Reactions (SUSARs). These are serious adverse events suspected to be caused by the medicinal product under investigation. The update proposed is remove the legislative requirement for sponsors to directly report SUSARs to investigators, because there are other ways investigators can receive this information. The MHRA also proposed that sponsors should be allowed to assess the causality of some serious adverse events through reviewing cumulative data rather than single occurrences. Opinion was mixed. Those who did agree considered that aggregate data in the Investigator’s Brochure may be more informative for investigators than SUSARs received in isolation. However, there was concern that the proposal would limit the access of investigators to relevant safety information in real time. The MHRA surmised that the responses highlighted a misunderstanding of the current procedure and that in addition to implementing the proposal, they will also provide clear guidance documents to accompany the legislative changes.

Sponsors currently provide a list of every individual serious adverse event and reaction in an annual safety report. The MHRA proposed the alternative approach of providing a discussion of the signals/risks identified during the year, to improve the quality of the information provided, since a robust discussion would help understand the most meaningful events. The MHRA will proceed with this legislation change. However, they highlighted that sponsors will still have the option to include them if they choose to do so, for example if preparing a report utilised globally.

• To extend the written notification for Urgent Safety Measures from no later than 3 days from when the measure was taken, to no later than 7 days.

The MHRA proposed that where sponsors and/or investigators take urgent safety measures to protect the safety of trial participants they should have a maximum of seven, rather than three, days to inform the MHRA in writing, to align with the timeframes internationally.

• To remove the requirement to report SUSARs and annual

safety reports to Research Ethics Committees.

The consultation proposed these are sent only to the MHRA, rather than also being sent to RECs, because it is the MHRA’s responsibility to monitor the safety of ongoing clinical trials. The MHRA would then liaise with the REC as necessary if any action was required. Noting that the MHRA will still receive these and liaise with the REC as necessary, responses demonstrated that this would reduce the administrative burden.

When questioned if the responders agreed that the proposed safety reporting requirements reduce burden on researchers but maintain strict levels of safety oversight, there were many comments welcoming the changes but with a split in opinion (40.8% agreed and 38.2% disagreed). Respondents welcomed a risk-proportionate approach, but ultimately patient safety should not be seen as a burden and there was suggestion that whilst the proposed changes would reduce the burden on investigators it may increase the burden of sponsors by creating UK-specific requirements.

• For SUSARs reported to the MHRA in an aggregate manner, where justified and approved by the regulatory authority.

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06 GOOD CLINICAL PRACTICE that is proportionate and ‘fit for purpose’ for both researchers and regulators).

The consultation proposed several updates to introduce in legislation the ability to consider the different levels of risk when considering clinical trial practices. The survey also asked for what GCP principles are considered important to include or remove and the MHRA will directly refer to the principles of ICH GCP in the legislation.

• For service providers of electronic systems that may impact on participant safety or reliability of results to follow the principles of GCP.

• To change the current legislation to incorporate more elements on risk proportionality (to facilitate a culture of trial conduct

• To update current GCP principles to incorporate risk proportionality.

08 MANUFACTURING AND ASSEMBLY

“The MHRA will therefore enable in legislation a risk-proportionate approach”

The consultation proposed to introduce a definition of ‘noninvestigational medicinal products’ into legislation which would allow the MHRA to extend the concept to non-medicinal products that may currently be unregulated, to provide greater flexibility in the requirements for labelling clinical trial medicines, and to extend the current exemption for holding of a manufacturing authorisation specifically for investigational medicinal products (MIA(IMP)) to include diagnostic radiopharmaceuticals within a clinical trial.

• To introduce the term ‘non-investigational medicinal product’ into legislation to provide assurance on the quality and safety of these products.

The MHRA will publish detailed guidance to accompany the new legislation.

• Where a medicine is labelled according to its marketing authorisation (and no blinding is required) that specific clinical trial labelling may not be required.

07 SANCTIONS AND

Responses supported the proposal where it could be justified and subject to the publication of detailed guidance to provide details and examples of when reduced or no clinical trial-specific labelling may be acceptable. The MHRA will therefore enable in legislation a risk-proportionate approach to the labelling of clinical trial medicines, such as removing the requirement for a specific clinical trial label where an authorised product in its marketed packaging can be used.

CORRECTIVE MEASURES

The consultation put forward proposals for additional proportionate sanctions and corrective measures to support regulatory oversight of clinical trials.

• To enable regulatory action to be taken against a specific part of a trial rather than the trial as a whole.

• For radiopharmaceuticals used in a trial to be able to be exempted from the need to hold a Manufacturers Authorisation for IMPs.

Respondents largely welcomed this proposal, recognising that it would be inappropriate for a whole multi-arm trial to be halted because of specific concerns about a single arm. Existing powers on the ability of the regulator to amend, suspend or terminate a trial will remain in place. It is the intention of the legislation to enable regulatory action to be taken against both a specific part of a trial and/or the trial as a whole.

Manufacturers will need to hold a valid manufacturing licence and comply with Good Manufacturing Practice, to continue to assure the safety and quality of those products. The MHRA confirmed the exemption will only cover radiodiagnostics, not radiotherapeutics.

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09 DEFINITIONS AND

CONCLUSION

OTHER TERMINOLOGIES

56.7%

The consultation put forward proposals to update several definitions in the legislation to set out roles and responsibilities of sponsors and co-sponsors.

• To update definitions within legislation.

These included update to definition of ‘clinical trial’, ‘clinical study’, ‘low intervention trial’, ‘non-interventional trial’, and to replace the term subject with participant. When asked if there were any comments or concerns to the proposed updates to the definitions outlined, more than half respondents had no comments or concerns. There was strong support for updating and modernising the definitions. With regards to the UK definition of a ‘substantial amendment’, the MHRA agreed with comments to align with the EU definition and therefore will introduce the definition of a ‘substantial modification’ into legislation. For the change from ‘subject’ to ‘participant’ the MHRA confirmed this is to replace the term in the UK legislation and will not impact the terminology used in multinational trial documentation.

ee Agr d

The final section of the consultation sought feedback on the proposed changes overall.

When asked whether the proposed changes introduced improvements to streamline processes and removed unnecessary burdens to trial sponsors, the majority (56.7%) agreed.

When asked if there are other aspects of the Clinical Trials legislation that have not been considered, a number of respondents highlighted that further consideration was needed to ensure alignment with the EU clinical trials process (and also the USA in some cases). Many responders requested alignment to minimise duplication of work. The MHRA confirmed that whilst legislative changes may streamline approvals in the UK, the core documentation required will remain aligned with the international expectations. There was a request for guidance to be coproduced by regulators with stakeholders.

The MHRA do not consider that the proposals risk impacting people differently with reference to their protected characteristics or whether they live in NI, and the majority of responders agreed.

• To clarify which healthcare professional can act as Investigator in a trial.

When asked if they think the proposals could impact people differently with reference to their protected characteristics covered by the Public Sector Equality Duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998, the majority of responders expressed no opinion. The MHRA confirmed they are taking forward a number of changes to support greater diversity in clinical trials and to make the UK regulatory environment more attractive for sponsors to bring their trials to the UK.

When asked which healthcare professionals should be able to act as investigator, respondents gave support to expand the professional groups who can be an investigator and that this should be risk proportionate. Responses also highlighted the need to clearly define the role. With an aim to keep the legislation future proof, the MHRA will create guidance so that it can be updated as the professional practice changes.

• For appropriately trained and qualified members of the investigators team to be able to seek consent.

NEXT STEPS

Guidance will be given on determining the suitability.

Following the consultation, the MHRA will now work with lawyers to begin drafting the new legislation to introduce these changes into the regulation of clinical trials.

The information summarised in this article originates from the official MHRA guidance. Full detail of all proposed changes and responses can be found at ‘Government response to consultation on legislative proposals for clinical trials.

“respondents gave support to expand the professional groups who can be an investigator”

https://www.gov.uk/ government/consultations/ consultation-on-proposalsfor-legislative-changesfor-clinical-trials/outcome/ government-response-toconsultation-on-legislativeproposals-for-clinical-trials

Written by Stephanie Bettesworth

Safety and Medical Information Manager, Novo Nordisk 25

MANAGING COMMON MISCONCEPTIONS ABOUT COPYRIGHT IN MEDICAL COMMUNICATIONS As long as I cite my source, I can use third-party content in my articles, reports and presentations.

The reuse of published material in medical communications projects is common practice, but understanding how this activity intersects with copyright law can be confusing and fraught with misunderstanding. This can lead to a greater risk of infringement for your organisation.

Including attribution does not eliminate the need to obtain the copyright holder’s permission for use of content beyond the traditional limits associated with fair use. In a business context, to lawfully use more than brief quotations from copyrighted materials, you typically must secure permission from the respective copyright holders.

Here are some common misconceptions around content access and reuse, and tips for separating fact from fiction.

If I secure a licence to use a figure in a presentation, I should be able to use that figure again when presenting the same slide deck at another medical congress.

If a journal article is published as Open Access (OA), I am free to use and share with other employees as I wish.

For OA content, it’s important to understand the type of OA licence under which the content is made available. There are six main types of OA Creative Commons licences, each granting a different set of permissions for reuse under a specific set of conditions (for example, the requirement to provide attribution). While some of those licences authorise use for business purposes, several of them specify that reuse is allowed only for non-commercial purposes.

In addition, some rightsholders use their own forms of OA licences that have different terms from the Creative Commons licences. When using OA content, it is important to make sure you are using the content in a way that is consistent with the relevant OA licence and your company’s own OA policies.

A licence is typically specific to a particular use and does not apply to other types of uses of the content. A rightsholder’s grant allowing you to use a figure in a specific presentation only applies to that presentation use, and not to other uses unless specified. If you want to use the content in another presentation or in any other way, you will typically need to obtain a separate licence from the publisher.

26

I am presenting a slide deck in a symposium to a few hundred people, and I have included published figures in my deck.

Since I’m not providing printed copies or links to the presentation for attendees, I don’t need permission from the publisher.

We ordered paper reprints of an article, but I also want to e-mail the article to people. Because we paid for reprints, I don’t see any reason why I can’t scan the article and also distribute it electronically.

You still need to obtain permissions from the publisher(s) for the reuse of that content in the presentation. You will need to inform the publisher whether the content will be distributed in any way (print or electronic) beyond the primary use in the presentation.

An order for paper reprints does not automatically include the rights to create or share electronic copies. Most copyright holders sell, or licence, content based on format and type of use. Before changing the format — for example, from paper to electronic — check your agreement with the publisher or vendor carefully. If the rights to send copies electronically are not expressly included, you should seek additional permission from the rightsholder.

USING PUBLISHED CONTENT RESPONSIBLY Copyright protection exists to encourage the development of new and creative works that spur innovation. Using content in unauthorised ways may infringe on the legal rights of the copyright holder and could put you and your organisation at risk.

Read on to learn more common misconceptions about copyright and steps to take towards the compliant reuse of published content in medical communications.

In fact, according to the 2023 Information Seeking and Consumption Report by Outsell, Inc., the number of people with whom information is shared across professional Life Sciences environments has increased since 2020, with respondents sharing work-related content 8.3 times per week with 13 other people. Considering that 44% of content is sourced from external providers such as scientific journals, news sources, and other publications, there is potential for more than 46 instances of unlicensed sharing per employee per week if proper permissions are not in place.

Educating staff, as well as clients, about their rights and responsibilities when reusing published material for commercial use is essential to the daily role of medical communications.

By taking steps to balance employee reuse of published content with a strong copyright education and compliance program, your company can leverage today's rise in content sharing to help support collaboration and the development of important medical information in life sciences.

Written by Erin E. Callahan Senior Director, Information & Content Solutions, Copyright Clearance Center copyright.com

27

PHARMACOVIGILANCE CHALLENGES DURING MERGERS

& ACQUISITIONS

The future growth for many Biopharma companies is through mergers and acquisitions of other biotech organisations, as well as divestments of their own business units that do not align with the company’s future aspirations. According to pwc.com, in the first half of 2023, the pharmaceutical & life science sector ‘continues to use mergers & acquisitions as a strategic tool to drive growth...’, it is therefore paramount that Biopharma companies set-up efficient systems and processes that allow for faster (with clear strategies) and compliant transitions of pharmacovigilance systems.

In

2020

121

worth some in the

CORPORATE ACQUISITIONS

$67 billion

biopharmaceutical industry (hopefully) overcome! It is therefore very important that once the M&A deal is signed off, a clear implementation strategy is defined as to what the business aims to achieve from the deal and if there are any business-driven requirements and timelines (e.g., integration prior to data lock or dossier submission etc.) that need to be adhered to.

Mergers & acquisitions (M&A) within the biopharmaceutical industry are now the norm. According to Statista.com, in 2020 there were 121 corporate acquisitions worth some $67 billion in the biopharmaceutical industry. Even in the economic downturn, the desire for biopharma companies to thrive and grow was at the forefront. And whilst in 2022 there was somewhat a downturn in M&A deals, according to pwc.com 2023 is expected to return to significant growth. With this comes the need for biopharma companies to set up systems and processes, as well as dedicated teams, that will support the integration and/or divestment of an organisation or business unit.

Strategies can range from acquiring an organisation but making no changes (i.e., maintaining a standalone pharmacovigilance system) to embedding the new organisation into your current pharmacovigilance (PV) system to form one PV system. The latter is often the strategy that is riddled with challenges but long term, it is my own opinion that having a single PV system is the best solution, i.e., one QPPV covered by one PSMF.

During an M&A, what we know about the organisation from due diligence through to deal signature is only the tip of the iceberg and there are many challenges that remain to be discovered and

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CONSIDERATIONS FOR THE PHARMACOVIGILANCE SYSTEMS IMPLEMENTATION OF COUNTRY ORGANISATIONS

HANDING OVER ACTIVITIES AND DEFINING CUT-OVER DATES

QMS HARMONISATION

INSPECTIONS AND AUDITS

UNDERSTANDING (OR DEFINING) NEW ORGANISATIONAL STRUCTURE

REMAINING COMPLIANT

MANAGING INTERFACES WITH OTHER FUNCTIONS

ENSURING QPPV OVERSIGHT

PUTTING IN PLACE PV AGREEMENTS AND POWER OF ATTORNEYS WHILE ASSETS ARE TRANSITIONED

CREATING TRANSITIONAL PSMF

COMMUNICATING WITH EXTERNAL PARTNERS

CREATING TRANSITIONAL SOPS

When acquiring or merging with another organisation, a company will be inheriting risks (past and present) from their PV system. The key PV challenges often observed in M&A deals are maintaining compliance and remaining constantly inspection ready during the transition period. Other challenges observed during M&As include:

In every M&A deal, the following considerations need to be thought of and planned for throughout the transition, regardless of the strategy employed. These include: • Ensuring there is a vigilance agreement in place between the

acquiring company and the acquired company clearly outlining the responsibility of each party during the transition

• Lack of specialised teams to execute transitions (resource/

capabilities issues): each deal is different, but many have commonalities that require specialised skills

• Ensuring pharmacovigilance coverage in all countries impacted by

the deal, including those where the acquiring company may not already have a local organisation

• Resistance to change may lead to a high attrition rate (loss

of talent)

• Ensuring clear documentation of every decision made, including

the rationale and key actions taken (to be audit/inspection ready), in transition plans

• Preservation of deal confidentiality

• Early identification of interdependencies with other line functions

• Lack of compliance - people lose focus on maintaining everyday

business transactions

• Taking time to understand the PV system of the acquired

company including becoming familiarised with any external vendors the PV system might be outsourced to.

• Impact of acquired company on the existing organisation.

SPECIALISED TEAMS pharmacovigilance system. Utilising a CRO might bring in expertise required for a particular project and lessen the burden on your resources. However, training an internal team allows for the organisation to build a specialised team that can lead multiple deals simultaneously without the need for additional resources.

The setting up of dedicated teams responsible for the transition of PV systems will look different in each organisation. For some organisations, this will mean outsourcing the project management to a Clinical Research Organisation (CRO) or internally utilising existing pharmacovigilance Subject Matter Experts (SMEs) and training them on how to transition a

29

GOVERNANCE – PHARMACOVIGILANCE STEERING COMMITTEE (PHARMACOVIGILANCE)* TRANSITION LEAD(S)

PROJECT MANAGER

PV WORKSTREAM 1

PV WORKSTREAM 2

PV WORKSTREAM 3

PV WORKSTREAM 4

PV WORKSTREAM 5

PV WORKSTREAM 6

PV WORKSTREAM N

PV WORKSTREAM WS LEAD(S) WS SMES

Workstream lead (acquiring company) Workstream lead (Target company) * Establishing a safety steering committee is recommended for high complexity projects

EACH DEAL IS DIFFERENT Whilst there is no ‘one-size’ fits all solution because every M&A deal is different, the systems and processes that the organisation sets up will allow for the transition teams to adapt to each deal. And, if there is a clear strategy from the beginning, transition compliance can be maintained, and risks minimised.

It is important to remember that not every M&A deal will be the same, but understanding which systems and processes need to be put in place will ensure the teams adjust to each deal.

RESISTANCE TO CHANGE threatened (in both companies) about being replaced or about the possibility that the acquiring company may not need the talent from the acquired company.

Each M&A deal has different implications on the organisation and its people. It is therefore very important to remember the ‘human element’. People often become restless and might also feel DEAL CONFIDENTIALITY It must be accepted that, at the beginning of the project, employees will not know much, and will need to learn how to work with some degree of uncertainty. People will need to be guided to focus on what is known and not what is unknown. Confidentiality often means there

are unknowns, and so people may need to work with assumptions.

The key is not to lose focus by worrying about things that are beyond our control, but to be ready to deal with surprises immediately they are discovered. In short, always have a plan, but be prepared for anything!

LACK OF COMPLIANCE Teams in both organisations may become sidetracked from their everyday activities due to ‘supporting’ transitional activities, or being concerned and uncertain about the upcoming changes, which

may take away their focus. Managers need to ensure Subject Matter Experts’ (SMEs) workload is taken into consideration when deciding the SME resource that will be dedicated to support the transitional activities.

IMPACT OF ACQUIRED COMPANY ON THE EXISTING ORGANISATION Organisations need to ensure that throughout the transition, clear communications are made frequently, and transparency is maintained, as far as the deal permits. Where possible, reassurance should be

provided in terms of employees’ futures within the organisation and what changes the acquisition will bring.

CONCLUSION The pharmacovigilance system is one of the most audited and inspected features within pharmaceutical companies, and thus it is important that pharmacovigilance specialists are proactive and not reactive to potential issues and risks that mergers and acquisition deals might bring to an organisation. Using clear implementation strategies, dedicated teams within the pharmacovigilance organisation with the sole purpose of transitioning the pharmacovigilance system from one organisation to another and documentation of every decision made with supporting evidence and rationale, can help ensure a smooth transition process.

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Written by Miranda Malanga External Vigilance Engagement, Transition Manager, Novartis UK

PMCPA SOCIAL MEDIA GUIDANCE 2023 IN PRACTICE On 26th January 2023, the Prescription Medicine Code of Practice Authority (PMCPA) released the first Social Media Guidance publication. This is a huge step forward for the industry in the UK and sets a precedent for other Code authorities to consider issuing guidance within their jurisdiction.

This eagerly awaited guidance covers multiple topics and key aspects of potential company activities on social media platforms - from posting & sharing to hashtags and working with influencers. Within Pharma, social media is considered a “risky” activity and is not taken likely, but with this new guidance in place it gives some direction to companies to help navigate this ever important media and communication channel.

It is worth bearing in mind that the guidance is based on the 2021 ABPI Code of Practice and case precedent, therefore it does not create exceptions or amendments to the requirements of the Code. However, it is likely that in the 2023 Code update there will be some new & amended content to reflect this new guidance and the direction of the industry as a whole.

It is also important to note that all pharmacovigilance obligations and other regulations, laws and Code requirements still apply, regardless of the activity.

“the guidance is based on the 2021 ABPI Code of Practice and case precedent” 31

SO, WHAT’S THE CODE DEFINITION OF SOCIAL MEDIA? “Social media is a term used to describe websites and applications that enable users to create and share content and to interact with one another in social networks, for example:” It is great to have a Code definition as it is a starting point for companies and creates a simple scope for companies to work to when defining such activities.

X

LinkedIn

Facebook

Instagram

TikTok

YouTube

01

02

- the involvement of the company must be clearly and prominently stated from the outset to allow the recipients / participants / respondents / followers to understand such involvement from the beginning.

- companies are responsible for all material and activities disseminated / carried out by it or on its behalf, including by a third party, even if the third party goes beyond the scope of their contract with the company.

TRANSPARENCY

The guidance highlights that it is recognised that the definition of social media is continuously evolving, and companies must therefore understand the wider principles set out in the guidance.

As a starting point there are two fundamental principles to keep in mind with any social media activity:

RESPONSIBILITY

“contrary to the requirements of the agency contract”

For example, there is a case where an agency, that had previously worked on behalf of a company for the marketing of a prescription only medicine (POM), used their work as a submission for a marketing award and subsequently posted an announcement on Instagram regarding this. This was contrary to the requirements of the agency contract with the pharma company: the agency had failed to seek permission from the company, and had previously confirmed, upon request by the company at the end of the project, that they would remove and dispose of all company materials. However, it transpired that the agency had retained project material on a server which was subsequently utilised 16 months after the end of the project.

A breach of the Code was ruled but then successfully overturned on appeal. The board recognised that the definition of promotion under the Code meant “any activity undertaken by a pharmaceutical company or with its authority which promoted the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.”

Therefore, in this particular circumstance, the creative agency had not acted with the authority of the company as defined in the Code.1

that they followed up with the agency at the end of the project and received confirmation that the material subject to the contract had been destroyed. Further, the agency also did not seek or gain permission to use the material per their contractual obligations with the company.

WHAT ABOUT PERSONAL ACTIVITIES ON SOCIAL MEDIA?

My takeaway from this is that if a company follows the letter of the Code, and meets their own specified obligations within their contracts with third parties, this will stand them in better stead to defend a Code breach. It so often happens that companies prepare all singing, all dancing contract templates that cover their Code obligations well, but then fail to follow or meet their own standards. This company had been able to demonstrate

A company may be held accountable if it could be reasonably perceived that an employee is representing the company, and / or, if the company has instructed, approved or facilitated the individual and the activity.

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WHAT ABOUT POSTS MADE BY COMPANY AFFILIATES / OFFICES / HEADQUARTERS OUTSIDE OF THE UK? Another challenge for multinational pharma companies is that under the Code, the UK company (if one exists) will be held to account for the activities of their overseas affiliates if there is a UK nexus. This means they will be accountable for:

affiliate which makes specific reference to the availability or use of the medicine in the UK. 3. Where a UK-based or UK company employee interacts with any activity, e.g. to like, share or post.

1. Any activity carried out by the UK company or affiliate

NOTE: this is because it is likely that their UK connections and followers will also be exposed to the activity.

2. Any activity carried out with authority from the UK company or

WHAT ABOUT MONITORING & REPORTING OF ADVERSE EVENTS?

01

02

If the company (or an individual or third party on its behalf) becomes aware of an adverse event (AE) associated with a company product, it must be reported.

If a company becomes aware of an adverse event as a result of a post that is not the responsibility of the company, the company should signpost how to officially report AEs.

COMPANY ACTIVITY:

NON-COMPANY ACTIVITY:

See table below for a summary of the guidance.

Table summary of PMCPA Social Media Guidance 2023

References: 1. PMCPA Social Media Guidance 2023 2. AUTH/3583/11/21 - Complainant v ALK-Abelló Alleged promotion of Itulazax on Instagram

NOTES: 1. All activities on social media must be undertaken with caution.

2. All activities & materials on social media must be reviewed and approved according to your company’s standard operating procedures & policies.

3. The guidance includes a list of key considerations for the review of social media activities on page 5.

TOPIC

SUMMARY

1. Links

• •

Will be regarded as being part of the original post Companies must ensure that the linked content is appropriate (i.e. not promotion of a POM)

Links in company posts should be: • clear and the name of the link should be appropriate • clearly state whether the link is to the pharmaceutical company material/website or other noncompany material/website • Linked material should: • identify the intended audience and the company responsible for the material. It is possible to provide links to other information for the intended audience • include instructions for those who are not the intended audience in order to direct them to relevant information where required.

2. Mentioning other accounts

•

3. Hashtags and tagging

•

•

•

Account(s) mentioned should be appropriate Permission should be sought in advance e.g. if from an HCP consultant

Should be respectfully done, and relevant Chronology may be taken into consideration

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TOPIC

SUMMARY

4. Responding to misinformation / correcting inaccuracies

•

5. Signposting vs posting / sharing / re-sharing

Company policy should be followed It is acceptable to cross-reference to the SmPC / PIL / emc • Referenced information must not be promotional in nature or intent • Referenced information must comply with the requirements of the Code • All inaccuracies must be corrected •

Signposting: Points to information • Describes the nature of the information & who it is for • Should enable the viewer to decide if it will be relevant for them • Must not directly or indirectly promote a POM • Validation is required before access further information (e.g. to confirm HCP status) •

NOTE: As an example, signposting might be used to invite HCPs to register for a meeting.

6. Corporate news and announcements

•

7. Professional profiles and job advertising

•

8. Disease awareness for the public

•

9. Patient support

•

10. Meeting advertisements

•

11. Product and pipeline milestones

•

•

Can be shared on social media (but must not be product related) Must be appropriate for the public

Job titles & descriptions should avoid mentioning POMs, particularly alongside the indication, therapy area or product benefits • Product names / therapy areas may be acceptable in detailed “experience” section, requiring the viewer to actively search for it, e.g. additional clicks / scrolling

Purpose to increase awareness of a disease or diseases Provide educational information on the management of disease • Can encourage public to visit HCP to seek treatment • Must not promote a product • Material / content must be certified •

Can host information for patients who have been prescribed a particular POM (e.g. video of how to take a medicine correctly) • Must be hosted in a secure location & otherwise not available to the public (e.g. via a feed / random search) • Target audience must be clearly identified

Can be used to signpost (e.g. a promotional meeting for doctors) The advert / signpost itself must be non-promotional (i.e. no product / indications / claims etc.), but therapy area may be acceptable • Access to meeting / promotional content must be controlled & validated e.g. for HCPs only • Must highlight the intended audience • Must be examined •

Must be new & newsworthy information Must be tailored to the audience • Must include clear signposting for the intended audience • Must be factual, accurate, balanced and must not encourage members of the public to enquire about POMs • Must not promote an unlicensed indication / use • Combination of a product name and indication is likely to be considered promotional • Links to a press-release / article, must be hosted on a website tailored to the intended audience e.g. HCPs • Validation (either self-certification / controlled) • Should not repeatedly share this content •

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TOPIC

SUMMARY

12. Working with social media influencers

•

13. Promotion to health professionals and other relevant decision makers

•

14. Clinical trial recruitment

•

Must have appropriate expertise Are aware of the pharmaceutical company’s responsibilities and all other required obligations • Must declare from the outset that they are representing the company • Written agreements must be in place clearly defining the engagement and the legal, regulatory and compliance obligations that apply • Companies will be held accountable for actions of contracted parties, even if they go beyond the scope of the agreement •

Promotional content / material must be hosted in a secure location and not visible to the public Must be tailored to the audience • Must include clear signposting for the intended audience • Must be factual, accurate, balanced and must not encourage members of the public to enquire regarding POMs • Must not promote an unlicensed indication / use • Validation (either self-certification / controlled) • Must be certified and meet all relevant requirements (including prescribing information (PI) etc.)

•

Carefully targeted Must not raise unfounded hopes • Avoid referring to specific products • Include a description that supports appropriate people/patients in the disease area to click to find out more • Reviewed and approved by ethics committee prior to use (where applicable) •

ACRONYMS: POM – Prescription Only Medicine HCP – Healthcare Professional SmPC – Summary of Medicinal Product Characteristics PIL – Patient Information Leaflet EMC – Electronic Medicines COmpendium

Written by Daniel Sherry

Chief Consultant, RedefineCompliance Ltd.

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LEADING THE WAY FOR THE NEXT GENERATION OF DIGITAL MEDICINES INFORMATION: The new version of emc launches Datapharm is proud to announce the official launch of the new version of emc (medicines.org.uk).

The update to emc comes at the beginning of an exciting new chapter for digital medicines information. The new enhancements align with Datapharm's mission to improve HCPs’ and patients’ access to vital medicines safety information, improving their engagement with it, while fulfilling Pharma companies’ regulatory requirements.

WHAT IS EMC? emc (electronic medicines compendium) is a comprehensive resource containing information on over 10,000 prescription and over-the-counter medicines, including details of their indications, dosage, side effects and contraindications. It currently draws in a global audience of over 84 million visitors per year.

Medicine safety information on emc comes in a range of formats, most notably SmPC, PIL and ePIL, and is widely trusted by UK healthcare professionals as a single source of truth. Prior to being published on emc, this safety information is reviewed and approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

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WHY DATAPHARM DEVELOPED A NEW VERSION OF EMC It enables linking of information between healthcare systems

On the surface, it is easy to see the visual enhancements which have been brought to emc. Not only is it more intuitive to use on a range of devices (including mobile and tablet), but the medicine page has also been carefully designed to ensure that the most popular features, and the most used SmPC sections, are within easier reach.

The benefits of adopting a common standard go beyond just the medicine information itself. Consider whether the medicine information can be linked to the patient.

However, beyond the current user experience, there is a deeper reason to why emc has been updated.

Using a common standard means that this medicine information is structured in a certain way. Currently on emc, the data is semi-structured, which you can see in the way that SmPC information is grouped by sections.

It enables automation of processes which are a significant cost to Pharma

“this enables the healthcare ecosystem to benefit from new automations in the future”

The healthcare landscape is about to see a major evolutionary step in how medicine information is linked between healthcare systems.

Currently, UK healthcare uses a range of systems (e.g. EMIS health, NHS dm+d, MIMS) for exchanging information around medicines. Currently, these systems cannot fully interpret and communicate with each other – so if you were to change information on a medicine in one system, the others would remain unaltered. This lack of integration means there needs to be a manual process to ensure that information is updated on the other systems.

However, if all these systems adopt a common standard for how their information is coded, this enables these systems to talk to, and understand, each other in a way they previously haven’t been able to. Furthermore, this enables the healthcare ecosystem to benefit from new automations in the future, so that updated medicines information in one healthcare system could automatically flow through to others.

The implications for Pharma are huge; this could significantly reduce a number of manual processes involved to ensure that all published information stays up-to-date and compliant.

This may be a small example of what can be done by structuring data from a common standard, but there are some much wider reaching implications.

When this common standard is used to its potential with fully structured data, this will enable information to be personalised to the patient.

For instance, the information could be tailored by making it appear bigger or smaller according to their visual needs or to highlight important pieces of information which are particularly relevant to their patient record, e.g. highlighting a medicine’s contraindication which could affect a pregnant patient.

37

This has great implications for patient safety in our healthcare industry, helping to reduce prescribing errors by linking medicine information effectively to the patient.

leaflets (PILs) and are being adopted by Pharma companies to present their product information to patients in a more accessible way.

It fits the sustainable, digital-first approach

This is gaining momentum in the wider Life Science industry, meaning that all of UK Pharma will eventually be required to publish their patient safety information in ePIL format.

Pharma currently publishes patient safety information in PIL (Patient Information Leaflet) form, with an emerging format: ePIL, which is increasingly being used by Pharmaceutical companies.

The new version of emc has been designed to accommodate this. The ePIL format can enable Pharma to reduce both printing costs and compliance risk, supporting their drive for sustainability while doing so. It also means that patients with alternative needs, such as visual impairments, can more easily interpret the information (for example, through AI voice devices).

ePILs (electronic Patient Information Leaflets) are digital versions of the traditional paper-based patient information

SUPPORTING PHARMA’S ENGAGEMENT WITH HCPS These benefits in the latest version of emc are just some of the things which are going to become a reality, due to the work which Datapharm has been putting into medicines information platform. Many of the technical enhancements in emc are now ready to be fully realised and implemented into a new and improved way of exchanging and interpreting this vital information.

Datapharm is continuing to support Pharma with their medicine information, not only with improving internal processes, but also in gaining a real understanding about how prescribers are engaging with their product information.

For further information, please contact Datapharm at servicedesk@datapharm.com.

Written by John Moreland Product Manager, Datapharm

Medical Information Departments Do you need support with: Developing or updating medical information letters Writing Prescribing Information for prescription medicines Up-skilling on reference checking/copy review for materials developed by your marketing and medical teams Reference checking materials

We can help info@medicomsolutions.co.uk 38

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VICE-PRESIDENTS REPORT It is with great pleasure that I get to write the Vice President’s report for PIPELINE, not only because it’s my first one but also because I have some very exciting updates to share with you.

close eye on the release of finer details around the Windsor Framework due to be implemented on 01-Jan-2025 and will incorporate any further information into our current guidance.

There are a host of updates still to come and we’ll be holding webinars to convey those updates to our members as and when the resources are published.

I write this report having just attended our most recent face-to-face Committee meeting and it was really motivating to see the work currently being done by the Committee and the working parties.

One area of focus was the expansion of our Continuing Professional Development (CPD) activities. As many of you will know PIPA has been a professional accreditation association with a CPD points system of membership since 2010. For those of you who don’t, check out the ‘CPD’ page under the ‘Professional Development’ section of the website to see how you can collect CPD points and move up the membership ranking, thereby adding nominals to your title along the way. There’s still time in the current cycle to upgrade your membership, so make sure to upload your professional development evidence and start collecting CPD points now. Additional to the existing system, we have been investigating the possibility of applying external accreditation to our training courses, the benefit being that you obtain an externally recognised certification upon completion. Keep an eye out on the ‘Training’ section of the website for all available courses.

Lastly, I hope that you enjoy this latest edition of PIPELINE. Feedback, comments, and ideas for articles are always welcome.

If you have a general question, why not post it on either the PV or MI discussion forum on the PIPA website and don’t forget to subscribe so you can see the discussions happening amongst your peers and be a part of the conversation.

Furthermore, the Committee workstreams have been collaborating extensively to continue the updates to our guidance documents and resources on the PIPA website, including developing a Medical Information Business Continuity Plan Template and Guidance on the UK QPPV and National Contact Person. We will also be keeping a

“PIPA has been a professional accreditation association with a CPD points system of membership since 2010.”

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Chris Isaacs

PIPA Vice-President

MEET THE PIPA COMMITTEE 2023 POOJA PATEL

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President

Vice President

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Email: vicepresident@pipaonline.org;

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PV Compliance; PIPELINE Co-Editor PharmaLex

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Preparation and proof-reading of PIPA’s journal, PIPELINE.

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