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Issue 60

The Journal of the Pharmaceutical Information & Pharmacovigilance Association

January 2020

CAREER PROGRESSION BEYOND UK BORDERS? CHANGES TO IR35 LEGISLATION AND ITS IMPACT ON CONTRACTORS DATA INTEGRITY AND COMPUTER SYSTEM VALIDATION (CSV)

GROUNDHOG DAY… AGAIN WHY IS INSPECTION PREPARATION NEEDED? MI INSPECTION / AUDIT READINESS CHECKLIST PIPA PROFESSIONAL AWARDS ROLE OF A BIOSTATISTICIAN IN DRUG DEVELOPMENT PROGRAMS UKMI SURVEY OF PHARMA MI DEPARTMENTS – SUMMARY OF SURVEY RESULTS

£12.00 or Free for Members

WHAT IS COMPLIANT MEDICAL EDUCATION?

9 327005

ISSN 1478-3274

771478

CONTENTS 1

Letter From The Editors

Career Progression Beyond UK borders? Factors to consider when applying for international roles

Julia Day

Role Of A Biostatistician In Drug Development Programs Impact Beyond Clinical Studies

Natasa Rajicic

Data Integrity And Computer System Validation (CSV)

Emma Boulton

Why Is Inspection Preparation Needed?

Martin Baker

PIPA Professional Awards

Groundhog Day… Again

Fintan Moore

Changes to IR35 legislation and its impact on contractors

Liam O’Connell

Medical Information Inspection/Audit Readiness Assessment Tool

UKMi Survey of Pharma MI Departments – Summary of Survey Results

What is compliant medical education?

Rina Newton

President’s report

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 Editors: Pooja Shah, Dora Amene and Zeb Adomako-Mensah Design and Print: Zebrahouse Design and Print Ltd

www.zebrahouseprint.co.uk

LETTER FROM THE EDITORS By Pooja Shah, Dora Amene & Zeb Adomako-Mensah

Happy New Year! Welcome to the first PIPELINE edition of 2020. We hope that you had a restful break with your loved ones and are fully refreshed and ready for what lies ahead this year. 2019 was a busy year largely revolving around Brexit and what that means for all industries, including the pharmaceutical world. We hope that there is more clarity over the next few months.

appealing. Julia Day, EU Divisional Manager at CK Group, offers a look at considerations for medical information and pharmacovigilance professionals seeking to move from a role in the UK to one overseas.

We have a jam-packed edition of PIPELINE with a variety of articles you will find interesting.

We also feature an interesting article by Fintan Moore where he reflects on 20 years of writing monthly columns for the Irish Pharmacist.

Our President, Ejaz Butt, reflects on the highly successful PIPA conference last October and the key takeaways for the PIPA membership. We also present 3 delegate accounts of the sessions they found particularly useful.

The above represent just a few of the many fascinating articles we have compiled for this edition and we hope that you thoroughly enjoy them.

The inaugural PIPA Professional Awards introduced at conference were a huge success. We have an article which discusses how the nominations work and how you could end up being a winner at this year’s conference. Also featured are interviews from last year’s winners and how these awards have helped enhance their career development, soft skills and/or confidence building.

The committee continues to work tirelessly to ensure that PIPA drives operational excellence and enhances and shares best practices for medical information and pharmacovigilance across our membership. To that end, please look out for the following over the next few months: • Regular webinars covering medical Information and pharmacovigilance hot topics

The overall results from the UKMi survey of Medical Information (MI) departments are also presented in this edition which we hope will help MI teams improve their current service offerings.

• Face to face and online training courses for continuous professional development • Guidance documents about medical information and pharmacovigilance standards

Following the Inspection Readiness session presented at conference, Martin Baker (Medical Information Manager at Alliance Pharmaceuticals Ltd and PIPA committee member) summarises the key messages and learnings on why inspection preparation is needed. We also present PIPA’s updated Medical Information Inspection/Audit checklist which covers key elements to bear in mind regarding this topic.

• PIPA Conference 2020 • Code Compliance and Managers’ forums • …and much more! As always, all feedback is welcomed, and we encourage you to interact with us, and the wider PIPA membership, via our online platforms below:

Have you heard of IR35? What’s changing and when? Liam O’Connell, Director of CK Group examines the changes to the IR35 legislation and its impact on contractors in the pharmaceutical industry.

• Official PIPA Website: https://www.pipaonline.org/

Ever wondered what biostatisticians in pharmaceutical companies get up to? Natasa Rajicic, ScD Principal, Strategic Consulting, Cytel Inc offers an interesting perspective on the role, specifically with regard to clinical trials, and how it interlinks with other aspects of the clinical development pathway of a drug.

• Twitter: @PIPAtweet

• LinkedIn: https://www.linkedin.com/company/ pipa-pharmaceutical-information-andpharmacovigilance-association Details of all our current training offerings and webinars will also be communicated via these online platforms. Until the next edition of PIPELINE, we hope you have a great start to the year and a delightful winter. If you want to contribute to PIPELINE, please feel free to contact us at journaleditor@pipaonline.org.

For many professionals, the opportunity to work in a different country for at least part of their career is hugely 1

CAREER PROGRESSION BEYOND UK BORDERS? Factors to consider when applying for international roles By Julia Day

For many professionals, the opportunity to work in a different country for at least part of their career is hugely appealing. This article looks at considerations for medical information (MI) and pharmacovigilance (PV) professionals seeking to move from a role in the UK to one overseas. A global workplace

languages are always useful where teams are cross cultural. The ability to speak the host country’s native language also helps, of course, to integrate more easily into social environments.

The pharmaceutical and medical communities are truly global, and recruiting companies understand that securing the right candidate often requires a worldwide search. At CK Clinical we’ve seen a trend in new medical information / affairs and safety roles in Switzerland and Germany, mainly owing to the Head Offices in question being situated in these two countries. Interestingly, though, at least half of the candidates we have placed in these roles have been from the UK.

MI professionals • What’s the set-up of your current UK medical team and what do you take accountability for within that? • Are you able to demonstrate an active role in escalated enquiry responses and the adaptation of medical materials for local or regional use?

The experience gained from working on an international assignment, possibly with regional variations, could position a candidate well against those who remain in the UK throughout their career. Similarly, it may afford the opportunity to work on a wide range of products before they are released in the UK.

• Are you involved with code governance and does this relate to the European Federation of Pharmaceutical Industries and Associations (EFPIA) as well as the Association of the British Pharmaceutical Industry (ABPI)? If not the EFPIA, what accountability do you have with the ABPI compliance from a medical information or medical affairs perspective?

Skills assessment When working with a professional who is considering a career overseas, CK Clinical poses the following questions:

• Are you responsible for a given therapy area and does that responsibility extend to being the internal point of contact for that therapy, either locally or regionally?

PV professionals • How quickly can you get up to speed with that country’s legislation?

• Are you fluent in any other languages? Whilst there may be no requirement to work in any language other than English in international roles, the ability to speak a second language is expected for local roles.

• Can you demonstrate subject matter expertise, e.g. in clinical safety, data interpretation, signal detection activities or the interpretation of regulatory aspects of clinical safety? How easily can this be translated into responsibilities at a global level?

Personal decisions Relocating to a new country of course has an impact on home as well as professional life - both for the individual in question as well as his or her family. Where are the best neighbourhoods? Which amenities are easily accessible? Are there large open spaces? Is there a thriving arts culture? A strong gastronomical scene? An appealing work-life balance? The suitability of a

• Are you prepared and qualified to take on the responsibilities of a global role above and beyond that of a regional or local affiliate role? • Do you speak any other languages? Whilst they are unlikely to be prerequisites for most roles, additional 2

• Effective communication and collaboration skills both cross culturally and cross departmentally (with global safety physicians as one example). • Leadership in change management. • Budget preparation and planning competence. • Preparation of study-specific safety management plans. • PV scientist mentorship. • Leadership of global PV operations. MI professionals

new overseas life will depend very much on personal circumstances and interests.

• Active listening skills and the ability to liaise with both the medical community and public.

Some considerations are more universal: cost of living and accommodation (and whether to sell or rent out any UK property); which possessions to ship, sell or place in storage; transport links, commute times and decisions on buying a car; taxation; any visa or work permit requirements; and perhaps childcare, schooling and a partner’s employment options.

• Ability to communicate complex product knowledge and in an unbiased way. • Competence in working to pace and across multiple channels of communication including live chat and video. • Confidence in working with key opinion leaders.

Some of this can be researched online; however, multiple field trips (even if only long weekends) will give the closest indication of what life is like as a resident, not visitor. It also presents the opportunity to engage first-hand with any other international staff about their experience of integration and also to identify any active ex-pat community.

• Ability to see the bigger picture regarding the market access process for drugs and therapies; particularly how factors such as branding and pricing can present barriers. In a world of uncertainty, what is within an individual’s grasp is the adoption of a clear plan on career progression. Those professionals who have clearly analysed their skills and addressed any gaps accordingly will be in the best position to exploit future opportunities wherever they might lie.

As with any job offer in the UK, the same diligent research into an overseas employer should be applied before accepting. Speaking to current staff, ideally in the same department or team, will give a useful insight into working practices and opportunities for career progression. How comfortable the HR Department are in facilitating this is, in itself, a litmus test of company culture. The strength of social networks, too, amongst colleagues (formal or otherwise) may be important, particularly for those individuals who are moving without family members.

If you would like further careers advice or information on European/international roles please contact Julia Day at CK Clinical. 01246 457719 jday@ckclinical.co.uk

Skills beyond boundaries

ckclinical.co.uk

An increased reliance on artificial intelligence (AI) in producing earlier and more granular characterisation of safety issues as well as more rapid analysis of data will place increased emphasis on skills beyond scientific expertise. For both PV and MI professionals, business skills are becoming ever more critical, with employers seeking strong evidence of the following:

Julia Day EU Divisional Manager CK Group

PV professionals • Confidence in prioritisation and risk management. 3

ROLE OF A BIOSTATISTICIAN IN DRUG DEVELOPMENT PROGRAMS Impact beyond clinical studies By Natasa Rajicic

Statisticians contribute to clinical study design, conduct, analysis and reporting - where their involvement has been well established. They are typically part of a larger biometrics team where they work closely with clinicians, data managers and programmers, and contribute to the study design, protocol writing, dataset formats and monitoring plans. For example, one of the main deliverables for a statistician working on a clinical study is the completion of a Statistical Analysis Plan (SAP) where they detail the statistical considerations. These include the planned sample size, statistical approaches for the evaluation of endpoints and testing the stated hypothesis, definitions of the analysis populations and estimands, and the treatment of missing observations, to name just a few.

However, the input from a statistician with broad experience in different quantitative strategies goes beyond sample size considerations, creation of the SAP document, and summaries of the results. When they are given the room to work closely with clinical pharmacologists, data scientists and other types of quantitative strategists, statisticians can take a broad view of the clinical development plan to synthesise existing information and consider the range of pathway options. They can help detect any knowledge gaps, identify the right data needed for present and future

needs, and help manage the risks along the way. The best statisticians are knowledgeable both about a product and its clinical development pathway, and about a whole range of quantitative approaches and strategies that can be employed to better inform decisions made along the development path. Their contribution can add to data-driven decision-making at every stage of the development. Their evaluation of the existing data can feed into the design of the trial through historical controls, help identify a high-value sub-population, or evaluate the collection of patient-centric measurements. They 4

for the overall development plan and beyond, so they can use their quantitative skills and strategies to help identify data gaps, help gather evidence needed for the key stakeholders mentioned above, to allow for better informed decisions in ‘real-world’ settings. Therefore, clinical development teams need to re-evaluate how to optimally employ the skills of various quantitative strategists, including the statisticians, across the whole product lifecycle.

can help forecast a more realistic enrollment schedule, use optimisation tools to characterise different clinical pathways, or help plan smarter resource allocation. During the drug development phase, companies naturally tend to concentrate on a single audience: a regulatory agency who will ultimately review the submission package and decide on a marketing approval. Yet the regulatory agency is only one of many stakeholders for whom the drug developers need to generate and present evidence and data. Therefore, if the data is accounted for throughout the program, rather than mainly concentrating solely on agency approval, companies have a golden opportunity to gather valuable evidence that could speak to all future stakeholders which, at a minimum, includes prescribers, patients, payers (stakeholders of the healthcare sector who are involved in the budget allocations and payment for medicines etc.), and the public.

Statisticians remain core members of clinical study teams. However, keeping them out of the overall strategic planning is an opportunity missed and has some considerable risks that may not become apparent until it’s too late. As I heard one of my former non-statistical colleagues say at one point, it is essential to have a statistician included at all times, you don’t always know when a statistician’s input and perspective is what you’re missing.

To be able to do this, statisticians need to be brought in as equal partners early enough in the process. Often, they are introduced after a study design has already been settled on, with their input reduced to simply the sample size considerations and the execution of the analysis plan. That could be an opportunity missed. Instead, they should be involved in the broader planning

Natasa Rajicic, ScD Principal, Strategic Consulting Cytel Inc

PIPA CONFERENCE

DATA INTEGRITY AND COMPUTER SYSTEM VALIDATION (CSV) By Emma Boulton

Trevor has 25 years’ experience in the pharmaceutical industry as an IT, CSV and Data Integrity specialist including 15 years in Quality Assurance for sponsors, service providers and as an independent consultant. Trev has taught on the MSc in Quality Management at Cranfield and teaches at the University of Hertfordshire on its MSc course in Pharmacovigilance. Trev is a Fellow of the Research Quality Association (FRQA) and is a tutor for Quality Risk Management and Data Integrity. He is currently the Chair of the RQA’s Digital Information Governance Information Technology (DIGIT) committee and Cross-GxP Data Integrity working party. Trevor’s 25 years of knowledge about this very niche topic was both engaging and enlightening. His presentation started with some key definitions and took us through the data integrity aspects of validation with a tie in with the General Data Protection Regulation (GDPR).

What is a computer system?

requirements for a specific intended use or application have been fulfilled.

It’s a set of hardware, software, procedures and people which together perform one or more data capture, processing, analysis and reporting functions, e.g. on regulatory study data.

Proving that the system is fit for purpose The presentation then moved on to the Good Automated Manufacturing Practice (GAMP) and the problems that can be encountered when deciding the GAMP software category that an application consists of into:

What is validation? The Food and Drug Administration (FDA) define validation as establishing documented evidence which provides a high degree of confidence that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

• Cat 1 – Infrastructure Software - Qualified installation (name, version), indirectly tested through use of application • Cat 3 – Non-Configured Software - Qualified installation (name, version), indirectly tested through use of application

ISO 9000 define it as confirmation by examination and through provision of objective evidence that the 6

PIPA CONFERENCE • Cat 4 – Configured Software - Qualified installation & configuration. Testing of configuration (operational qualification (OQ)/ performance qualification (PQ))

There are 4 steps for validation, as listed below:

• Cat 5 – Custom Applications - Full lifecycle support and validation

3. The intended purpose documented as per point 1

1. A system of Quality Assurance 2. A GxP risk / critical assessment as per point 1

4. Evidence the system performs to 3 as per point 1 and in accordance with point 2

However, Trevor stated that the categories follow the rules outlined below:

Trevor was keen to reiterate that risk assessments for a system should start during the planning stage and continue through to system retirement (see image 3).

• If I write a PV System that can be configured for the individual, it is Cat 5 • If I sell a service provider (SP) that system, for the SP it is Cat 4 • If I sell ‘pre-built configurations’ to the client, it is Cat 3* *This is somewhat theoretical and significant testing would be recommended. Moving on to validation, typical validation models and risk assessments are shown in images 1 and 2.

Image 3

One of the risks there are with our GXP systems is that data integrity, and therefore GDPR, requirements should be embedded as part of the risk assessment and continue through the system lifecycle. If GDPR is not embedded, you need to question how a request received to erase or correct someone’s personal data can be achieved, and how can you prove that it has been done? In a world of product transfers being more and more frequent, this issue can quickly escalate and become an issue that no-one wants to face.

Image 1

Initial Risk Assessment • GxP risk / determination • System impact • What is the data supporting? • Licenced products • Clinical trial data (primary / secondary endpoint / reconstruction)

Image 2 7

PIPA CONFERENCE

Planning Risk Assessment

• Success requires a partnership between QA, the business, IT & engineering to mitigate the risks to the data

• Supplier assessment • Lifecycle / deliverables approach

• CSV must follow a controlled process

• What do you need to validate?

• To get a positive result to data integrity validation you need negativity. In simple terms, sometimes a test needs to fail to confirm the system works as expected/ required. In PV terms, if you are testing reporting rules it’s as important to test that rules won’t work, or fire as expected as well as testing that they do work or fire in the right circumstances.

Another scenario that Trevor described to us is audits. The right to audit and inspection support is routinely put into contracts and agreements but what does that mean? Are locations, and therefore legal jurisdictions, agreed upfront as well? Trevor told a humorous story of going to an audit in the US for a client. The team of people that were needed for the audit had travelled from India to the US. When the sessions were being run, the body clock of the poor auditees was telling them it was the middle of the night and they should be asleep. Which wasn’t the most productive environment for an audit.

Trevor gave us an invaluable insight into the world of data integrity and how it relates to what we do on a daily basis. Personally, my take home was a better understanding of what is involved in validating a system and to ensure that GDPR, data integrity and validation of the system’s use should be part of contract set-up and review with vendors.

Summary • Data integrity is always intended to be a focus of CSV • Focus on the data criticality & specification of its requirements

Emma Boulton

• GDPR - understanding subject data and their rights

Napp Pharmaceuticals Ltd PIPA Committee Member

• The validated system should be based on the data flow within the system. From intake through to outputs (i.e. ICSR reporting, line-listings etc.) 8

PIPA CONFERENCE

WHY IS INSPECTION PREPARATION NEEDED? By Martin Baker

It is a good question and one that I feel was effectively answered at this year’s PIPA Conference. The session was led by Ranjana Khanna, Head of Pharmacovigilance Quality Assurance at Vifor Pharma. Ranjana has over 15 years of experience in the pharmaceutical industry and through a combination of PowerPoint slides and role-plays, she delivered an interactive and engaging session; sharing her personal experiences, learnings and some useful dos and don’ts on inspection readiness. Interestingly for me, one of the main take home messages from the session was the development opportunity an inspection could offer MI and PV professionals. Let me try and explain.

inspection will typically follow - as well as the right of an inspector to amend the inspection plan e.g. by adding new topics to the agenda, calling additional staff for interview and/or adjusting timelines.

The session opened with a recap of some of the laws and regulations that govern and drive inspections in the European Union. Then the role and responsibilities of the Inspector was described, and we were all reminded that an inspector’s job is to identify potential deficiencies in the company’s system(s) (e.g. a non-compliance which could pose a risk to the patient and/or public health), so we shouldn’t take these personally.

The crux of the presentation rightly focused on what we can all do to effectively prepare ourselves and the company for an inspection. Ranjana shared some very useful insights that could make all the difference, for example:

Ranjana then went into a good amount of detail regarding how an inspection should be conducted: general rules of engagement, timelines and a description of the flow an

• Establish a core inspection team • Set up a Subject Matter Expert (SME) list

PIPA CONFERENCE • Agree on the logistics, dates, site and facility where the inspection will be held

ask the inspector for further clarification • Sometimes a little more information is useful, ‘I think so’ answers are poor responses from a responsible person OR subject matter expert.

• Have all trainings completed prior to the first inspection day • Be aware of current issues/potential areas of concern in your function and know if corrective measures have already commenced

Ranjana closed the session and talked in detail about several key roles involved in an inspection: • Inspection lead

• Familiarise yourself with the previous inspection findings and/or recent audit observations relevant for your function

• Inspection moderator • Scribe

• Have I.T. support on the day to manage any unexpected errors and to support with information sharing across different locations and time zones, if required.

• Runner • Document controller She described the key attributes, qualifications and character traits people performing these duties successfully need to show.

Building on this understanding, the second half of the session focused around 3 role-play scenarios that were acted out. The audience where then asked to provide feedback on how well the auditee in the scenario had done at answering the inspector’s questions. The audience then appraised the quality of the responses by analysing what went wrong and sharing some tips on how the auditee could have answered the questions better. For example, some of the tips that were shared were:

Know what you do 3

• Remain professional, keep on topic and answer the questions being asked

Say what you do 4

Do what you say

Prove what you did

• Be confident. If you don’t understand the question – From a personal development opportunity, it is important to note that getting involved in an inspection could open some doors as well as increase exposure to other areas of business. Personally, I left the session feeling much more confident with a better understanding - and appreciation of – the amount of work that goes into successfully hosting an inspection and how best to prepare yourself, your team, department and/or company. If you have any questions or would like to receive some more information on this session, please contact me on martin.baker@alliancepharma.co.uk

Martin Baker Medical Information Manager Alliance Pharmaceuticals Ltd

PIPA PROFESSIONAL AWARDS

PIPA CONFERENCE

At this year’s PIPA conference, we introduced the new PIPA Professional Awards for Pharmacovigilance (PV) and Medical Information (MI), designed to recognise outstanding achievements of pharmacovigilance and medical information professionals within the industry. Both the MI and PV awards are split into three separate categories - best newcomer (0-2 years), best professional (2-5 years) and best senior professional (5+ years). As a committee, we felt that both PV and MI professionals should have a space for their achievements to be recognised and celebrated. So here we are, celebrating our industry’s finest. How do the nominations work? Only PIPA members are permitted to be entered for the awards, and the nominations can only be made by PIPA members. Individuals can nominate themselves, or be nominated by a manager or colleague. In either case, nominees must have company approval before their entry will be accepted by PIPA. The nominee (or person nominating them) is asked to submit a testimonial about why they should be considered for the award, explaining how they have demonstrated excellence in their field. The testimonial is then passed to the PIPA judging panel who provide a scenario, based on the nominee’s experience, which the entrant needs to write about and submit as their award entry. What is an example of a scenario? An example of a scenario for the Best MI Newcomer would be to write a general summary about how they would structure and approach a response to an interaction enquiry from a healthcare professional.

The scoresheets are sent to a member of the PIPA administrative team to add the overall scores together to determine the winner. All award entrants are required to attend the first day of the annual PIPA Conference, as the winners are announced during the evening meal and social event.

A nominee for Best MI Senior Professional may be asked to write a critical evaluation of a clinical paper. A Best PV Professional scenario could be based on how they would streamline a specific process to allow for efficiency and inspection readiness.

We hope that you will now consider which of your colleagues inspires you, impresses you with their development of new or improved processes, goes above and beyond for their role and, most importantly, displays professionalism. Perhaps you could nominate that colleague for the 2020 PIPA Awards?

Once completed, the responses to the scenarios are returned to the judging panel for assessment. How do the judging panel assess the responses? After the deadline to submit entries for the awards has been reached, each of the members of the judging panel independently review the responses to the scenarios. Checklists are used to assess the responses against specific criteria to ensure we have a fair and balanced marking scheme.

To be recognised by your peers is a great feeling and gives the person not only a sense of achievement but also highlights what they have brought to the business. Most importantly, receiving an award motivates them to continue their successful career path. 12

PIPA CONFERENCE

And now some words from our 2019 winners… Amy Doyle qualified as a pharmacist in 2017 and started her career as a community pharmacist before moving into hospital pharmacy, where she had her first experience of MI. Amy believes her experience in hospital MI enabled her take up her current position at Alliance, where she has been working for 16 months. Amy won the PIPA 2019 Professional Award for the Best Medical Information Newcomer.

Anita Lewis is a Senior Medical Information Specialist in the Medical Affairs team at Roche Products. She won the PIPA 2019 Professional Award for the Senior Medical Information Specialist. She started her pharmaceutical career at Roche 10 years ago and has had several roles within the company including a Therapy Area Advisor, Medical Information Manager and a Medical Writing and Publication Manager. She is now, primarily, home based and works 4 days a week as a Medical Information Specialist, which she feels is great for her work-life balance. She feels that technology has greatly improved over the past few years, allowing her to feel truly part of an office-based team.

Tell us how it felt to be nominated and to win in your category? I think the MI team at Alliance is great. They have supported me through every step of my development, so to find out that my manager considered my contributions worthy of a nomination felt awesome!

Tell us how it felt to be nominated and to win in your category?

I hope the team sees this win as a win for the team, as well as the individual, as they are very much a part of the reasons for this success. Thanks guys!

It was a lovely surprise when my manager nominated me for the award. Winning has definitely increased my confidence and looks great on a CV! There are so many great members at PIPA, I felt very humbled.

How do you see yourself developing career-wise?

Even though I have had a wonderful time working in MI, I have decided to embark on a bit of a career change. I am soon to start working as a Medical Writer for a medical education agency. I am very excited to develop my scientific skills, take on this new challenge and to see where this move will take me.

I really enjoy working in a Medical Information department and love the fact that within my role I have direct daily contact with patients and healthcare professionals. I have a varied role and enjoy the fact that enquiries and projects are different every day. At Roche I have been lucky enough to get involved with new digital projects such as an MI ChatBot, which has been really exciting and challenging, especially from drug safety and regulatory perspective. In terms of developing, I feel settled in the role, and would like to extend our digital technology within the Medical Information department.

Do you think award schemes, like PIPA’s, help you in any way - whether it is career development, soft skills, confidence building etc? If so, how?

It felt really rewarding to receive an award for the piece I wrote on critical appraisal, as this is a skill that I will be using often in my new role. Receiving this award has given me a confidence boost, which has helped me find new energy and enthusiasm to tackle the new challenges I will face.

I see lots of awards in other pharmaceutical areas, such as sales and marketing, so it is great that Medical Information professionals finally have the opportunity to get recognised for their work. I feel that the award scheme will motivate people to do their best. I especially think it’s great that there are 3 awards for people in different periods in their career: recognising newcomers to the industry, as well as people who have been in the role for a longer period of time. My colleagues in other 13

PIPA CONFERENCE departments have heard of the award and have since asked about PIPA, and what it does, so the award also promotes the society.

The introduction of the PIPA awards offers the opportunity to recognise the great work being done across the industry and will aid often unsung Medical Information teams raise their profile within their own companies.

Jack Chivers is a Medical Information Associate at Alliance Pharmaceuticals Ltd. After graduating with a degree in Pharmacology from the University of Hertfordshire in 2015, he worked in aseptic manufacturing before starting his career in Medical Information at Alliance in January 2017. Jack won Best Medical Information Professional at the PIPA 2019 Professional Awards.

Lily Elson was awarded Best Pharmacovigilance Professional at the PIPA 2019 awards. Her degree in Biology included a year-long professional placement, during which she worked at Cancer Research UK’s Centre for Drug Development (CDD), mostly in the Pharmacovigilance Team, but also providing support to the Quality Assurance and Regulatory Affairs teams. After graduating, she returned to the CDD as a Pharmacovigilance Associate and was then promoted to Pharmacovigilance Scientist about two and half years ago.

How do you see yourself developing career-wise? My current role is a good balance of medical information activities, project work and copy approval. I am committed to continuing to progress within medical information and further refine the skills I have developed. Looking beyond that I see my career taking one of two possible tracks. The first would be to build on my scientific background either by engaging with healthcare professionals through the legitimate exchange of medical and scientific understanding as a medical science liaison or by supporting commercial colleagues with medical input as a scientific advisor. The second track is to focus more on the copy approval aspects of my current role and pursue a career in compliance. Both options have their own appeal and I feel my grounding in Medical Information has equipped me well to pursue either option.

Tell us how it felt to be nominated and to win in your category? I was really surprised but grateful to be nominated for the award. It was great to be recognised by my colleagues at an industry level. How do you see yourself developing career-wise? I hope to continue to develop my skills in PV, whilst also developing in other areas that interest me. I am soon going to start a part time secondment as a Medical Writer which I am really excited about. I hope that this secondment will help me to broaden my skillset and will expose me to other aspects of drug development. Do you think award schemes, like PIPA’s, help you in any way - whether it is career development, soft skills, confidence building etc? If so, how?

Tell us how it felt to be nominated and to win in your category? To be nominated for the Best Medical Information Professional 2019 Award was very humbling and I would like to thank my colleagues for putting me forward. Working as part of the Medical Information team at Alliance is my first job in industry and I very much see this as a team award as much as an individual one. I feel very honoured to have received this award at the PIPA conference which, as always, was an interesting and educational event. The sessions I find most valuable are the open forum discussions on Medical Information best practice and how different companies approach the same situations.

Yes, definitely. It is great to be recognised by my peers and reaffirms my confidence in my work. Attending the conference was a great opportunity to network with others in the industry. Marion Autour-Duff won Best Pharmacovigilance Senior Professional at the PIPA 2019 awards. She studied pharmacy in France, followed by a pharmacy residency, during which she worked in different hospitals in Paris, at the French Regulatory Authority (ANSM), and within the pharmaceutical industry at Servier Headquarters as a clinical trial coordinator. She moved

Do you think award schemes, like PIPA’s, help you in any way - whether it is career development, soft skills, confidence building etc? If so, how? 14

PIPA CONFERENCE to the Servier UK office 6 years ago as part of her last residency semester. After finishing, she was offered a temporary, and then a permanent position (so ended up staying in the UK much longer than she had initially planned!). Marion started as a Pharmacovigilance and Clinical Operations trainee, then a Pharmacovigilance Officer and finally, 3 years ago, was promoted to Pharmacovigilance Manager.

Anjna studied Biological Sciences with Molecular Genetics BSc at the University of Warwick. For the past few years, she has been working towards completing her MSc in Pharmacovigilance at the University of Hertfordshire.

Tell us how it felt to be nominated and to win in your category?

To be nominated was very exciting and gratifying. This is the first time I have been nominated for an industry award, and I was delighted to see that my collaboration and hard work was valued by my colleagues. I didn’t expect to win and was surprised when I heard my name being called out!

When I received an email to notify me that I had won a PIPA award for being the highest achieving student in 2018/2019 I was very surprised! I felt honoured that the Pharmacovigilance MSc Exam Board had selected me and that I had been invited to collect the award at the PIPA conference dinner. It was a fantastic evening and I truly appreciated the kind words from my lecturer who presented the award. Studying whilst working fulltime can be challenging so it was very motivating and encouraging to be recognised for the hard work.

Anjna won the University of Hertfordshire MSc Pharmacovigilance award at this year’s PIPA 2019 Professional Awards.

How do you see yourself developing career-wise? I am happy in PV, as in my current position I have many interesting challenges and am taking on extra responsibilities beyond the role of a typical PV manager. I am working to continue to grow my core skills in PV, while taking on new challenges in areas which interest me. For example, I am currently training to become a Code signatory for Medical Affairs. I can also see myself working at a global, rather than local, level in the future and am driven to continuously improve both culture and process at a team, and organisational, level.

How do you see yourself developing career-wise? I hope to continue to be challenged and grow in my career within the pharmaceutical industry. I hope to be exposed to development opportunities that will enable me to gain a breadth of experience. I think this will help me to progress my career within Pharmacovigilance and continue to work on interesting projects.

Do you think award schemes, like PIPA’s, help you in any way - whether it is career development, soft skills, confidence building etc? If so, how?

Being nominated for, and receiving, this award has helped me gain confidence in the work I am doing. It is proof that those who work hard are recognised, which I believe is a great message to be sending - and culture to build - especially in areas like PV and Medical Information, where people are not necessarily very vocal about their achievements. On a personal level, this award has already helped me gain visibility within my company and on an industry level.

I have already found that the MSc in Pharmacovigilance has helped me with my career development and I hope the PIPA award scheme will also help in the future. For now, it has helped by giving me confidence in my ability to complete the MSc at a time when I needed it and has also motivated me to do my best on my MSc project.

Anjna Chopra is a manager in the Safety Evaluation and Risk Management team at GSK. She has been at GSK for a number of years and prior to her current role, she worked in the case management group at GSK. Prior to starting her career at GSK, she worked within data management and pharmacovigilance roles at Cancer Research UK, MSD and Takeda. 15

GROUNDHOG DAY… AGAIN Fintan Moore reflects on 20 years of writing for Irish Pharmacist By Fintan Moore

They say that time flies by when you’re having fun, but it passes pretty quickly when you’re working too. The days might occasionally drag a bit but you can blink and realise that a few years have gone by in what seems like no time at all. At any rate, that was how it felt to me when the Editor let me know that I’ve now been writing a monthly column for 20 years. As the saying goes ‘the past is a different country’, and 1999 certainly had its differences to today — pharmacies were still regulated in terms of where they could open, the only School of Pharmacy was in TCD, and the morning after ‘pill’ was an off-label dose of two Ovran 30 tablets. Things have certainly changed in some ways. On the other hand, I took a look back at what was exercising my mind two decades ago and some things haven’t changed much at all. 1999: Celtic tiger

obnoxious, cheer yourself up by looking at their patient history – they will almost invariably have a record of insomnia, stomach ulcers or heart disease.

There’s no town like a boomtown. Everybody making loadsamoney and buying bigger houses and faster cars. Sitting in the sun outside a coffee shop drinking espresso, or else in the shade in a wine bar sampling a crisp Chardonnay or an earthy Merlot. Every window has a ‘help wanted’ sign, but every week you walk by more beggars and step over more sleeping bags. The average Joe is mortgaged to the neck to buy a shoebox, and spends three hours a day commuting, watching other lemmings scream abuse at each other for stealing five yards of road in a traffic jam. The newspapers keep talking-up the party and there’s no sign of the good times stopping rolling.

Do not fill Valium 10mg containers with Warfarin 3mg tablets and leave them in your drug safe for syringeraiders. The ethical pharmacist wouldn’t even think of this. Computers do NOT respond to physical or verbal abuse. Accept the fact that ‘upgrades’ aren’t and ‘help-desks’ don’t. Computer terms like ‘help-desk’ and ‘telephone support’ belong to the same lexicon as ‘military intelligence’ and ‘political integrity’. 2000: ‘Natural’ Remedies It’s hard to keep a straight face at times when people ask if you can order some totally obscure product that even health-food shops can’t source. Did you know that you can buy ‘Beaver Fat Capsules’ to protect you from the effects of ageing? Apparently, because of the high levels of bark in the beaver’s diet, its body fat is particularly rich in beneficial tannins and antioxidants. Actually, I just made that up, but there are people who would swallow it, and would pay handsomely to do so. I think over-regulation of the ‘natural medicine’ market would be wrong, but the leeway that has existed for charlatans to exploit the unwary has been crying out for attention. Especially if you put the words ‘weight loss’ on anything, you will find people to use it, as long as they don’t have to walk to the shop to buy it, and can eat a bar of chocolate to survive the drive home.

Yeah, London in 1999 was a lot like Dublin today. 1999: Packaging Design Do the people who design the packaging for drugs ever consider the ‘nuts and bolts’ of the dispensing stage in a drug’s journey from factory to patient? One company’s antibiotic liquid is protected by a paper seal beneath the cap. The seal is gummed so tightly that after you tear it, you have to scrape the remnants off the mouth of the bottle with a blade (a fingernail would work, but hygiene forbids that). 1999: Thoughts Inspired by Baz Luhrmann’s ‘Sunscreen’ Remember the compliments you receive. Forget the insults, but if someone is unreasonably and aggressively 16

2000: Translation Service

that another college, say UCC, has a brand-new School of Pharmacy now producing 50. So, in the year 2010, having somehow assessed that there is definitely a glut of pharmacists — where do you cut the number of graduates? Henry Kissinger once said ‘university politics are so vicious precisely because the stakes are so small’. I can’t picture either institution meekly accepting a cut in student numbers and related funding so we could expect any Minister for Education to long-finger the hard decision and maintain the status quo.

Sales rep: ‘There are three free with 12 on that.’ Translation: ‘… but only one will actually arrive in the order.’ Sales rep: ‘That order will be out before the end of the week.’ Translation: ‘… but I didn’t say which week.’ Sales rep: ‘Payment will be made by direct debit.’ Translation: ‘So you can’t compensate for lousy service, slow credit note handling and delayed delivery of owed (but already invoiced) stock by not paying us on time.’

1999: Patient Tales My favourite story goes back a couple of years to the weekend of an American Football match in Croke Park between the US Army team and the US Navy team. As usual on these weekends, there were hundreds of American servicemen out on the rip. One of our Methadone patients arrived with the most hung over, bloodshot eyes that I’ve ever seen — try to picture a rabbit with hay fever in headlights. He proceeded to tell us that he was having a gargle in some pub the night before and he’d bumped into a bunch of US Army fans. So he asked them:

Pharmacist: ‘Oh, Mrs Murphy! Those tablets we owe you are coming in this afternoon’s delivery. We should have them by four o’clock. I know I said ‘today’ — I really meant this afternoon. Sorry about that. Alright so, see you later. Bye now.’ Translation: ‘Crap! I knew there was something I’d forgotten to order!’ 2000: Premonition of Doom I may have found the Payments Board to be efficient, but there are reasons for concern. The DPS fee is too low, especially with both broken bulk and container fee axed. The drug list is too restrictive. If we will ultimately be required to validate DPS and medical cards, we had better be paid to do it. Some pharmacy computer boffins have warned against moves towards online validation of prescriptions. Is drug budgeting in the pipeline?

‘Did youse know that dere’s a big population of Vietnamese here in Dublin? Yeah, dey all came over in boats after the war and dey stayed. An’ do ya know wha? Dey should get together and form an American Football team… and then dey could wipe yer backside all over again.’ He was clearly living proof of the adage that there’s a god who looks after fools and drunks.

2000: Pharmacy top-Ten chart

1999: Condom Buyers

No. 10 ‘Lyclear, Right Now’ by Fatboy Slim.

Worse again is Mr Remarkable. This guy just can’t buy condoms without making some asinine remark about the fact. If he buys a 12-pack, it’s ‘Stocking up for a long weekend – you know yourself.’ Wink wink.

No. 9

‘Je Nicorette Rien’ by Shirley Bassey.

No. 8

‘Ibuleve I Can Fly’ by Boyz 2 Men.

No. 7

‘Pharma Chameleon’ by Culture Club.

No. 6

‘I Should Be So Losec’ by Kylie Minogue.

No. 5

‘Livial Next Door to Alice’ by Dr Hook.

If he buys an 18-pack, it’s ‘Off on holidays. Ibiza Uncovered, here we come.’

No. 4

‘You’ve Lost That Loving Feldene’ by The Righteous Brothers.

A mere three-pack is only ever ‘just in case I get lucky. Friday night — you never know.’

No. 3

‘You Are Olbas On My Mind’ by John Denver.

No. 2

‘Mirena On the Wall’ by Suzanne Vega.

No. 1

‘A Noriday in Paradise’ by Phil Collins.

Look mate, just buy the condoms. People buying toothpaste don’t have to say: ‘Just keeping the teeth white’, or ‘dental hygiene — can’t be too careful, you know yourself.’

2000: Pharmaglut

The more things change, the more they stay the same.

How would the powers-that-be decide that there was an over-supply of graduates? What benchmark do you use to measure supply and demand? Let’s assume further that TCD is still producing 70 graduates annually and

If I’m still writing in 2039, I wonder what will be different! 17

CHANGES TO IR35 LEGISLATION AND ITS IMPACT ON CONTRACTORS By Liam O’Connell

At CK Clinical, part of the CK Group, we employ many professionals who work at our client organisations on a contract basis. Due to this we are keen to offer them the best information possible in order to keep them up to date and allow them to make informed decisions regarding the new IR35 legislation. Here is some of the information we have shared with them: What is IR35? IR35 is a set of tax laws which form part of the Finance Act. The first piece of legislation came into force in April 2000 and is properly known as the Intermediaries Legislation. IR35 takes its name from the original press release published by the then Inland Revenue (now HMRC) announcing its creation. IR35 is a set of tax rules that apply to you if you work for a company through an intermediary – which can be a limited company or “personal service company” which is how many contractors operate.

It is not mandatory for client companies to use CEST to determine the IR35 status of their contractors, but HMRC have said they will stand by the results given by CEST, unless any checks reveal that inaccurate information has been submitted. It is critical that proper and thorough assessments of each assignment are made, rather than attempting to apply a single, all-encompassing status determination to all contractors.

What’s changing, and when? In October 2018, the government confirmed that it would be extending the off-payroll rules to the private sector. As of 6 April 2020, the responsibility for IR35 assessment will shift from the intermediary (usually the contractor’s own personal services company), to the employer. The draft legislation was published on 11 July 2019.

What do contractors need to know?

The changes will also make private sector employers (or the fee-paying agency acting on their behalf) responsible for making the correct deductions for the tax and National Insurance Contribution of their contractors who are assessed to fall within IR35. This will bring the private sector IR35 legislation in line with its public sector equivalent.

The shift in responsibility for IR35 assessment means that client companies will need to ask their contractors questions in order to make accurate assessments. Contractors should therefore be prepared to provide information relating to the ownership and management of their personal service companies, including:

How is IR35 status determined for contractors?

• How many other clients the company works with

HMRC has created a tool called ‘Check Employment Status for Tax’ (CEST). Employers can answer a series of questions presented by CEST to assess their contractors’ IR35 status.

• The types of insurances held by the company • Unique Taxpayer Reference number and VAT numbers. 18

Contractors should note that it is permissible under data protection law for client companies to request this information for the purpose of remaining compliant with tax legislation, provided they process the information in accordance with data protection law.

• The company’s turnover must not be more than £10.2m • The company’s balance sheet must not be more than £5.1m • The company must have fewer than 50 employees.

The assessment could result in a change of status for contractors that places them inside IR35. This will mean deductions for PAYE and National Insurance will be taken by the fee-payer before the contractor is paid. Some employers may offer to increase their payments to compensate for this, and others may choose to offer contractors employee status or a PAYE contract with the company. Companies are not obligated to offer any compensation or alternative business arrangements, however, and the contractor should therefore decide what conditions they would find acceptable if they are deemed to be working inside IR35.

Anti-avoidance rules will be introduced to prevent organisations from restructuring in order to avoid the new legislation. Medium-to-large companies may attempt to pass responsibility for IR35 assessment from themselves to the fee-payer (or agency), if a fee-payer is involved in the supply chain. However, it is unlikely that fee-payers in the supply chain will be willing to accept the resulting liabilities. Regardless of whether the employer or the fee-payer assumes responsibility for the IR35 determination, the decision must be cascaded throughout the supply chain so that all parties are aware of their obligations. This should provide contractors with the opportunity to discuss their IR35 status as assessed by the client, and dispute it if necessary. Disputes are to be a client-led process of consultation.

It is an offense to avoid paying the taxes resulting from their assessed status, and contractors should be highly cautious if engaging with agencies or umbrella companies operating in any of the following ways: • Disregarding the employers’ decision regarding the contractor’s IR35 status

What should contractors do?

• Offering to pay contractors a large percentage of their renumeration ‘tax-free’

In the first instance, all contractors should be taking advice from their accountants with regard to their likely IR35 status.

• Offering loans, offshore arrangements or other proposed solutions to paying taxes

CK Group can provide assistance if you find you need to receive payment through an external company. If you would like more information, please contact Liam O’Connell at the CK Group here:

• Offering to present contracts so as to make the contractors appear outside IR35. All of the above factors could be deemed disguised renumeration tax avoidance by HMRC.

01246 45700 Loconnell@ckgroup.co.uk

Finally, contractors who find themselves assessed inside IR35 should note that while they will be liable for paying employee tax, this does not mean they are entitled to employee benefits. Paying employee tax currently does not equate to full employee status. The government is reviewing this, and looking to bring employee tax status in line with full employee status.

ckgroup.co.uk

Are there any exemptions from the new legislation? The changes will only affect medium-to-large private sector companies. Small employers will be exempt from the new legislation, in which case it will remain the responsibility of their contractors to assess their own IR35 statuses. As per the Companies Act 2006, two of the following three criteria must be met in a particular year in order for a company to be classified as ‘small’:

Liam O’Connell Director of CK Group

MEDICAL INFORMATION INSPECTION/AUDIT READINESS ASSESSMENT TOOL In the April 2017 edition of PIPELINE, we published an article, written by Salma Ibrahimo, on Medical Information Inspection Readiness. The article aimed to provide guidance for medical information teams preparing for inspections, and included a checklist to help identify key points to focus on during their preparation. The PIPA MI Workstream reviewed this checklist at the end of 2019, and have made some updates to ensure that it is still current. An electronic version of this document can be downloaded from the PIPA website via: https://www.pipaonline.org/Medical-Information-Inspection-Readiness-Checklist Document Process Do your MI processes align with global and regional documentation, and if there are any local variations are these documented? Can you describe each step? Can you clearly indicate the relationship with Pharmacovigilance and Quality Assurance to ensure adverse events (AEs) and product quality complaints (PQCs) are reported? Are you able to describe the process for handling MI requests on safety related topics? Can you retrieve all up-to-date MI applicable standard operating procedures (SOPs)/working practices and any relevant documented local business processes? (e.g. SOPs/working practices describing company requirements and processes followed by MI staff to report AEs/PQCs, to comply with copyright, data protection etc). Process Details If you have a local policy/regulatory requirement of retaining hard copy source documents, then ensure your archiving procedure is clear. If you are taking detailed paper notes prior to logging into your database, ensure the notes are scanned and attached to the system. Do you provide an out of hours service? If so, do you have a process flow chart or documentation to support this service? Is testing of the service performed and adequately documented? If you do not provide an out of hours service, do you have a process to ensure AEs and PQCs are handled/processed in the required timeframe (if reported) (e.g. left on voicemail after business hours, during a holiday shutdown, system outage)? Do you have a current disaster recovery/business continuity plan that covers your processes, as appropriate? What type of back up do you have for your department to show continuous daily business hour coverage? (i.e. to ensure AEs and PQCs are handled/processed in the required timeframe). Process Roles Job descriptions - does a job description exist for all positions in MI (contract or permanent)? (The job description should describe all key activities of the current role). Training Can you provide the role based curriculum for MI in your country/location if asked? Are training records for MI staff complete? Do you have an onboarding/training program for new MI staff? Is this documented?

Yes/No

Are the onboarding/training materials (slide decks etc.) for MI staff easily retrievable? For training completed outside of the training system, e.g. external courses, training at conferences, etc. have you added these to your training system and do they show in your electronic training transcript? If not, do you have documentation (e.g. training roster[s]) as a record of the training? For other types of training that you provide (e.g. sales representatives, external business partners [e.g. call centre agents] etc.), do you have retrievable training materials and training rosters? Personnel Is an up-to-date CV available for all MI staff (permanent and contract, including all call centre staff [if any])? Are CV(s) easily retrievable if requested? (Note: CVs for contract staff may be held by the supplier/vendor but should be readily available on request). Are CV(s) updated, signed and dated on an annual basis? Does the CV align with the job description i.e. do the skills and qualifications of the personnel in the role (this includes past employees) match with those required to perform the job? Do you have an up-to-date organisational chart? Contracts Do you have service contracts for outsourced MI service providers (if any)? Are these contracts easily retrievable? Do these contracts depict clear procedures for the handling of AEs/PQCs reports by these partners? Monitoring Can you describe the quality monitoring program for your database/system? Do you know who to contact globally if questions outside of your scope are asked? Do you have a process for monitoring the quality of MI responses provided by outsourced MI service providers? If so, is this process documented? Can you show evidence (documentation) that this is conducted on a regular basis? Do you have a documented approval/withdrawal process for non-promotional materials that the medical information team are responsible for creating/updating/disseminating e.g. scientific decks for MSLs? Do you perform spot checks on random job bags/materials to check for compliance with the process? If you are involved in the provision of risk minimisation materials, do you have a monitoring process in place to ensure that these are sent in line with the specific productâ€™s risk minimisation plan? Regulations Can you show how you document off-label MI requests (if required) and/or off-label patient exposure? Can you describe how you determine if patient exposure is off-label? Can you show how you comply with data privacy and copyright regulations applicable to your country/ location? Inspection For your department/location, have you assigned the appropriate inspection designee(s)? (Departments/ locations may have one or more personnel designated as the point-of-contact for inspections). Have all MI staff received inspection readiness training? And is this documented? Are you aware of any previous audit/inspection findings impacting MI? Are they resolved? If they are not resolved, can you explain the status of those findings?

UKMI SURVEY OF PHARMA MI DEPARTMENTS Summary of Survey Results Background PIPA and UKMi have worked in collaboration for more than 20 years. As part of this collaboration, at regular intervals throughout the years, UKMi staff have surveyed Pharma MI teams, and – usually a year later – Pharma MI teams have run a reciprocal survey of UKMi services. The UKMi/PIPA liaison group designed questionnaires that would supply meaningful information to Pharma regarding the quality of the interaction experienced by this important customer group. In quarter 2 of 2019, UKMi staff recorded the details of all the enquiries they submitted to pharmaceutical MI teams over a two week period. During this period, 133 different pharmaceutical companies were contacted with 178 product enquiries. An overview of the results of the survey were presented at the PIPA Conference in October 2019, and this was used as a basis to initiate a discussion around what the results mean for MI in the industry, and the implications for best practice. After conference, a detailed report was sent to the MI manager for each company contacted during the survey period. As part of this feedback, further information was requested to help quantify some of the questions asked later in the survey, and this additional information is included within this article.

The Results

Was it easy to contact the Medical Information Department?

Contacting The Medical Information Department How was the MI department contacted?

• Communication issues where English was not the first language • Too many options to listen to

How were the MI department contact details obtained?

• GDPR statement / disclaimers too long • Telephone line closed when it should be open • Telephone not answered, no voicemail option so emailed instead

eMC (SmPC or PIL) Pharmaceutical company website

• Team not available

Other

• Google • Another company

• Transferred to the wrong team • Answer machine rather than call handler • No email available, so phone the only option • No phone number available, so email the only option 23

If no, was an acceptable timeline agreed?

TELEPHONE ENQUIRIES

Why did you use the telephone as the way of contacting the MI department? 9

70%

Quicker initial contact

Comments regarding timelines:

Required an immediat e response 41

Prefer to speak to someone

• “Still haven’t received information, no deadline agreed.”

Complexity of enquiry - discussion required 25

30%

Other

• “No - it was answered nearly two days late after we chased them TWICE.”

Other reasons listed for contacting the department by telephone: • No response to email

• “I was informed that it could be some time as it was to be referred to another department”

• Quick response required

• “I asked to be called back asap but no one called”

• Follow-up question from previous enquiry

• “Signposted as product transferred”

• Quick and simple enquiry

• “Yes – for the next day”

• “Easier to specify a particular deadline - emails seem de-prioritised”

• “Yes she rang back in 10 minutes” • “No time was agreed as enquirer said they would call back, no call was received.”

How would you rate the telephone manner of the staff?

• “I was provided with some info immediately but enquiry has to be referred to global team” • “I wanted an immediate response which they were unable to give me but said they would let me know within 48 hours” • “No but an answer was provided within 24 hours” • “An acceptable timeline was agreed. Information on the query was given in writing”

How would you rate the knowledge / competence of the MI staff?

• “Response already 2 weeks late” • “No timeline was mentioned. He said he would get back to me as soon as he could” Was your enquiry resolved within an acceptable timeframe? 10 10

Yes

Was your enquiry answered immediately?

No Not possible to assess yet 80

For enquiries not resolved within an acceptable timeframe:

EMAIL ENQUIRIES

Main feedback given was either:

Why did you choose to email the MI department?

• The response was late / hadn’t yet been received or • Enquirer had to chase for a response

Other feedback:

Didn’t require an immediate response Request for standard information

• “Only main part of response received.”

Other

• “This phone call was actually a follow-up from an outstanding enquiry. We had waited a week for a response, but this time we got the answer instantly when we phoned.”

Quicker initial contact Complexity of enquiry

Other reasons for using email to contact the MI department: • Audit trail required

• “Technically no, I called back to prompt if response was ready after had not been called back the next day. Was told initially on the phone that this was still being worked on. Was then phoned back to say the answer had been completed but was left out of central system, which may not have been discovered had I not prompted. They were honest about it which was good.”

• Ability to cc other colleagues involved with the enquiry • Easier to email • No phone number available • Unable to contact company by telephone

• “Was told will call back in 10 mins. I had to call again an hour later to get the answer from a colleague as it was urgent. The answer was already available so not sure why the delay. Colleague did mention it would get fed back.”

Did you receive an automated response to your enquiry?

• “Had to chase, response was ready but they did not contact me back within agreed timeframe.”

29%

• “It took a long time to receive a response, only to be told that there was no information.”

71%

If yes, were timelines included in the email?

40%

60%

Was your enquiry resolved within an acceptable timeframe?

“Said 10 working days. 2 weeks later rang company and they had forgot to send me their findings.”

ALL ENQUIRIES What was the information requested required for?

Other reasons given for why the information was requested: • Safety • Specific advice for a specific cohort of patients • Foreign language PIL • Supply For which reasons did you choose to contact the company for information?

Other reasons given for why they chose to contact the MI team: • Confirmation of their understanding of data • Further information • In-house unpublished data • Manufacturing process information • Fridge enquiry / stability data • Other resources not useful

How would you rate the quality of information provided?

• Lack of confidence in response due to incorrect information being provided by another company previously • Lack of understanding of the enquiry • Concern over quality of information / not clearly answered • No new information Could the company have helped you better in any way?

The UKMi staff who indicated that the quality of response received was poor or very poor were asked to explain why. These points summarise the main themes in the feedback received: • No further information provided – standard “clinical decision” answer

36%

• No information provided further to that in the SmPC

64%

Those that answered that they felt the MI team they contacted could have helped them better in any way, were asked how. The main themes in their responses were:

• Incorrect guidance / information • Lack of understanding of question • Didn’t answer the question

• Need to respond in a timely fashion / agree timelines

• Answer not specific enough to enquiry

• Information available, but it cannot be shared

• Response was late

• Lack of stability data and information on alternative administration routes

• Didn’t receive answer

• Poor quality of data in SmPC

Do you feel confident with the response you received?

• Regurgitation of information in SmPC • Question asked not answered • Unable to open document links provided

89%

• MI as middle man

11%

• No literature search undertaken

For those who answered no to feeling confident with the response they received, the respondents were asked “why not?”

• Verbal responses not confirmed in writing • Confusing or contradictory response • Data provided not completely up-to-date

These are the themes covered by the responses:

• Response rushed

• “Info received was good, but no further guidance provided”

• Data missed

• “As information required could not be provided ending up in clinical decision” • No information provided • Poor response • Not enough information – further research required

Who did you think you were communicating with?

For the 10 companies whose MI function is in-house, 27 enquiries were reported on. Of these, 23 (85%) of the enquiries were correctly identified as being responded to by an in-house team. However, for the 5 companies who solely use an out-source MI provider, 11 enquiries were reported on and no enquiries were correctly identified as being handled by an outsourced team. For these enquiries, respondents felt that 9 (82%) were dealt with by an in-house team, and the other 2 enquiries were logged as ‘not possible to tell’.

Anecdotal feedback from some UKMi staff indicates that they believe that they can tell when they are speaking to an outsourced medical information team vs an in-house one. The respondents were therefore asked to indicate who they thought they were talking to for each enquiry: 20

The company’s in-house MI team A third party to which the MI function has be en outsourced

11 69

For the in-house enquiries, 11 (41%) were given a rating of ‘very happy’ for the overall experience; 14 (52%) had a rating of ‘happy’ and 2 (7%) had a rating of ‘disappointed’. For the outsourced enquiries, these figures were 4 (36%), 6 (55%) and 1 9(%) respectively.

Not possible to tell

When the individual feedback reports were shared with each MI department, the MI manager was asked to confirm whether their MI team is based in-house or outsourced, in an attempt to determine whether the perception of UKMi staff was accurate.

From the limited data available to analyse, there appears to be no firm evidence to support the suggestion that it is possible to determine whether an enquiry is being handled by an in-house or outsourced team, or that the experience differs depending on who handled the enquiry.

26 companies (out of 133) provided the requested information. Of these, 5 outsource their medical information function, 10 have an in-house medical information team and 11 use a combination of both in-house and outsourced medical information provision. Unfortunately, for the companies who use a combination of MI provision, there is no way to determine which of the enquiries reported on in the survey were handled in-house vs being answered by the outsource provider. It was therefore impossible to determine from the data for these calls whether the enquirer’s perception of the MI service provider was accurate or not.

Rating of overall experience The final question of the survey asked the respondents to rate how they felt about the overall experience for the enquiry:

30% Very Happy

45% Happy

23% Disappointed

2% Very Disappointed

Manager Pharmacovigilance Bourne End

PharmaLex is a leading provider of Regulatory Affairs, Development Consulting, Pharmacovigilance, Quality Management and Compliance consultancy services to the pharmaceutical industry. We are looking for an experienced professional to join our team in Bourne End, who can provide maternity cover for the following role; the role will be for the period March 2020, until January 2021, with potential for the role to become permanent. You will be accountable for the execution of operational tasks in the field of pharmacovigilance and also lead the coordination of projects where PharmaLex has been commissioned to take over comprehensive pharmacovigilance responsibility for a company’s medicinal product(s) in the pre-approval and post-approval phase. Key qualifications and skills for this role include the following • Degree in Natural Science or equivalent • Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance • Ability to organise operating procedures and to take over project management duties • General knowledge of pertinent medical or pharmaceutical issues • Detailed knowledge regarding project-related SOPs (internal and clientspecific), global PharmaLex SOPs and pharmacovigilance related SOPs • Professional verbal and written communication skills with internal and external clients We offer great benefits including: • 25 Days holiday plus BH (increasing to 27 after qualifying service) • 8% employer pension contribution • An opportunity to work within an organisation with a positive work/life balance environment • Continuous development opportunities through knowledge and experience as well as training If you are interested in joining our Pharmalex team, please apply online at: https://careers.pharmalex.com/Manager-Pharmacovigilance-maternity-covereng-j411.html

Photo by Martin Adams on Unsplash

WHAT IS COMPLIANT MEDICAL EDUCATION? By Rina Newton

The term ‘Medical Education’ is a term that is often misunderstood within the pharmaceutical industry, which then leaves companies exposed to potential breaches of the ABPI Code of Practice. The Code doesn’t specifically mention the term ‘Medical Education’ but it does refer in Clause 1.2 to ‘information relating to human health or diseases provided there is no reference, either direct or indirect, to specific medicines’ as a non-promotional activity. Importantly, this means that genuine non-promotional medical education cannot mention a specific medicine or class – otherwise this will be seen to be promotional. Of course, there are many other types of non-promotion (such as advisory boards) which do allow the mention of a specific medicine or class. For health professionals, medical education means keeping up to date with rapidly evolving clinical practice and technology so they are well-equipped with future skills and knowledge. It also allows them to complete their mandatory Continuing Professional Development (CPD), so represents a vital aspect of their professional lives. For them, medical education may cover any aspect of healthcare – from novel therapies and pathways to learning about guidelines and digital technologies. What can we do as an industry to ensure that we meet the medical education needs of individual health professionals and the wider NHS whilst always adhering to the Code? This is best addressed by first considering the risks and then their mitigation. What are the potential risks? We know there is a very clear definition for promotion in the Code: any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines. Conversely, there is no single definition for non-promotion as there are many types, ranging from medical education and advisory boards to legitimate exchange of medical and scientific information during the development of a medicine. Each non-promotional activity has its own set of criteria that must be strictly adhered to in order for that activity to then be considered non-promotional. It therefore follows that if medical education discusses medicines (even if only at a class level) AND the activity does not meet all the criteria for any other acceptable category of non-promotion, then it will be considered as promotion. This will be a breach of the Code if the medicine/indication is not licensed, or the material is 31

not certified, or the content does not include obligatory information for promotional material etc.

Therefore, our observations suggest there is more than just “comply with the Code” that needs to be advocated here.

When Roche1 organised a non-promotional medical education symposia at a congress, they engaged a speaker to discuss an area of unmet educational need. Although the speaker brief stated that no proactive mention of rituximab was to be made, two slides mentioned the product and the speaker referred delegates to a subsequent session, where rituximab data would be discussed. Thus, the Panel ruled that the symposia did not meet the criteria for medical education and it was therefore actually promotional (and in breach).

In terms of how risk can be mitigated, there is a very clear solution. It is a common misconception that by mentioning other companies’ medicines or even the entire class, this will in some way ‘balance’ the content so that it is not promotional. In fact, any mention of the company’s medicine would be viewed as promotion (or worse, pre-licence or off-label promotion) – plus the company has in part ‘promoted’ the medicines of other companies…

The industry sometimes has a hard time defining compliant medical education for a number of different reasons. Sometimes this boils down to just one thing – allowing compliance to be defined by external drivers rather than observing Code requirements.

In conclusion, compliant medical education should not mention a specific product or class of product. Whilst some may regard this as limiting, arguably this nonpromotional activity still has an important part to play in educating NHS health professionals and other relevant decision makers on health policy, research areas, patient perspectives and needs, healthcare systems, trial design, diseases, symptoms, markers, prevalence, prognosis, diagnostic techniques, digital health technology and so on.

When approving or auditing medical education meetings, we often see justifications for the appropriateness of planned activities. Examples of the language used are listed below: • “Medical have organised this so it’s ‘educational’ not ‘promotional’”

1. CASE AUTH/2598/4/13 CONSULTANT RHEUMATOLOGIST v ROCHE

• “The speaker is an international expert so it’s credible content” • “We can’t put prescribing information on as it’s a medical meeting”

Rina Newton Managing Director CompliMed

• “It’s being presented at a very reputable meeting” • “This is genuine independent content!” 32

PRESIDENT’S REPORT JANUARY 2020 PIPA’s busiest period has just passed with an extremely successful PIPA Conference. If you were part of the experience this year then I truly hope you enjoyed it as much as we enjoyed organising it. This edition of PIPELINE includes a summary of some of our sessions at conference by individuals who attended them. We also have a write up from our winners of PIPA’s 2019 inaugural PV and MI professional awards. As always, for those speakers who have given approval for their presentations to be shared, they are now available to all attendees via the member login on the PIPA website. I want to take this opportunity to reflect on the variety of aspects relating to the attendance of a PIPA Conference, and the benefits it has for all of our PIPA members. First and foremost, it provides you with access to speakers who are industry-leading subject matter experts with a wealth of knowledge and experience. The topics covered this year were really ground-breaking, technical, hot-offthe-press updates that relate to medical information and pharmacovigilance both directly and indirectly.

networking opportunity has great value to it and we see this as a huge bonus to PIPA Conferences; we saw a lot of people catching up with old colleagues and of course it provides a great opportunity to make new acquaintances – put faces to names that we regularly see on LinkedIn, for instance.

It’s all about Brexit these days. No matter what your views are on the topic, it goes without saying that it is already having, and will continue to have, an incredible impact on the way we work and where we work. We thought that getting an insight from the MHRA and ABPI would be useful and important to all of our members, so our morning sessions on the first day were from Mick Foy from the MHRA and Steve Hoare from the ABPI. We came away from it at least with some reassurances that there were thoughts and processes in place that we will need to initially follow should the situation require it. And a great opportunity for our members to ask the key burning questions that we have all been thinking about.

And, finally, a huge thank you to the returning exhibitors who have established such a great relationship with PIPA over the years, as well as welcoming new exhibitors and sponsors to the PIPA family. Once again, the benefits go directly to our PIPA members who gained access to the variety of exhibitors and had the opportunity to discuss, view and take away information on the services they can offer which are always directly relevant to our members.

We all like to work hard and play hard too, so the dinner and social event on the evening of the first day went down a real treat!

The committee took a very short break from all things conference but are now back to the grind of planning and executing the 2020 PIPA conference. Whilst we are doing this, it would be great to hear any suggestions you may have for next year’s event – please contact us via conference@pipaonline.org with your ideas. We also recommend that you secure manager approval for attendance early to ensure you don’t miss out on next year’s conference and can take advantage of our early bird rates once booking opens!

Then there were more technical discussions, where our delegates had the opportunity to select parallel sessions that suited their interests and roles. The second day of conference had a similar set up to the first, with parallel sessions on counterfeit medications, vendor selection in PV, MI workshops and building subject matter experts in your teams. This year, the topics were of equally great quality as before, often making it tough to decide which session to dip in and out of!

Ejaz Butt

The conference also offers the added value of having the opportunity not only to have one to one discussions with speakers, but to also network with the vast number and range of delegates over a coffee break or lunch. We, in the committee, think providing delegates with this

PIPA President Director of Audit Management PrimeVigilance

PIPA COMMITTEE 2020 Who are we? The PIPA committee is the backbone of the association; and this page features all the current contact details. The Committee is supported by 3 part-time contractors, whose details are also included on this page.

Ejaz Butt

Janine Gavin-Poulter Vice President; Code Compliance Sobi

President Zigzag Associates Ltd

vicepresident@pipaonline.org; code@pipaonline.org

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

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

Tracy Crooks

Sanjay Motivaras Training Workstream Co-Chair Audit PV Ltd

Treasurer Reckitt Benckiser

E-mail: training@pipaonline.org

treasurer@pipaonline.org

Role: Co-ordinating training courses for the PIPA membership.

Role: Financial lead / Audit & compliance / Invoice payment

Esther Straghan

Tazneem Anwar Medical Information Workstream; Communications & Profile; Member of Training Working Party Janssen Cilag Ltd

Training Workstream Co-Chair Pfizer Ltd

training@pipaonline.org Role: Co-ordinating online training courses for the PIPA membership.

medinfo@pipaonline.org; internet@pipaonline.org Role: Assisting the PIPA membership with ensuring excellence in MI. Raising awareness & engagement within & beyond PIPA.

Pooja Shah

Dora Amene PV Compliance; PIPELINE Co-Editor TMC Pharma

PIPELINE Co-Editor; Conference Co-organiser Cancer Research UK

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

journaleditor@pipaonline.org conference@pipaonline.org

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

Role: Preparation and proof-reading of PIPAâ€™s journal, PIPELINE. Assisting with PIPA Conference preparation and delivery. 36

Bhavna Bhatia-Sandom

Tom Nichols

Training Workstream Co-Chair Quality PV Services

PV Compliance; Communications & Profile Drive Phase PV

E-mail: training@pipaonline.org

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

Role: Co-ordinating training courses for the PIPA membership.

Charlotte Mason Medical Information Workstream Novo Nordisk Ltd.

medinfo@pipaonline.org Role: Assisting the PIPA membership with ensuring excellence in MI.

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

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

pv-liaison@pipaonline.org; conference@pipaonline.org Assisting the PIPA membership with ensuring their PV compliance. Assisting with PIPA Conference preparation and delivery. Updating and maintaining a CPD programme relevant to the membership.

Martin Baker Medical Information Workstream Alliance Pharma

medinfo@pipaonline.org Role: Assisting the PIPA membership with ensuring excellence in MI.

Sian Casey Communications & Profile; Member of Training Working Party; PV Compliance Roche

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

Sarah Anthony Administrative and Treasurerâ€™s Support (Contractor) PO Box 254, Haslemere, Surrey, GU27 9AF

sarah.anthony@pipaonline.org

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

sharon.braithwaite@pipaonline.o

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

Emma Boulton

Anne Turnbull

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

Operations Manager (Contractor) PO Box 254, Haslemere, Surrey, GU27 9AF Tel: 07904 164812

pv-liaison@pipaonline.org

anne.turnbull@pipaonline.org

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

Contribute an article to Pipeline or register as a contributor Could you impart knowledge that you have gained recently through work or training, which you feel the membership would find useful? We are always looking for new authors and are committed to providing you with an excellent range of topical articles from changes in the regulatory environment, promotion of new initiatives and sharing best practices. Articles can be 250 - 1500 words long. Please contact the editorial team with your ideas or article, or to register your expertise in a specific field so we can invite you to write on a specific topic our members would like to see in the next edition: journaleditor@pipaonline.org

ADVERTISE IN PIPELINE PIPA is an association of around 700 professionals who are employed in the Pharmaceutical Industry, predominantly in the fields of Medical Information, Pharmacovigilance and Compliance. Advertising to members can be undertaken via our journal, PIPELINE, which is published 3 times a year, a paper mailing or on the PIPA website. The PIPA membership list is confidential and is not made available to advertisers and non-members of the association. We also accept advertorials. Please let us know if you would like to write an advertorial rather than including a simple advert in the next or subsequent editions of PIPELINE. External agencies who wish to advertise with PIPA must have PIPA member representation within their organisation, and may only advertise services that are of benefit to the PIPA membership. For further information, advertising rates and/or membership details please contact: anne.turnbull@pipaonline.org

PIPA Journal Issue 60