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
60
CONTENTS 1
Letter From The Editors
2
Career Progression Beyond UK borders? Factors to consider when applying for international roles
Julia Day
4
Role Of A Biostatistician In Drug Development Programs Impact Beyond Clinical Studies
Natasa Rajicic
6
Data Integrity And Computer System Validation (CSV)
Emma Boulton
10
Why Is Inspection Preparation Needed?
Martin Baker
12
PIPA Professional Awards
16
Groundhog Day… Again
Fintan Moore
18
Changes to IR35 legislation and its impact on contractors
Liam O’Connell
20
Medical Information Inspection/Audit Readiness Assessment Tool
23
UKMi Survey of Pharma MI Departments – Summary of Survey Results
31
What is compliant medical education?
Rina Newton
34
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
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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