5th European Forum for Qualified Person for Pharmacovigilance (QPPV)

Event #1110511-12 May 2011 Hotel Novotel London St. Pancras, London, UK

Programme Co-ChairsVicki edwardsSenior Director, European Pharmacovigilance, Abbott Laboratories, UK

margaret WaltersDirector, EU Pharmacovigilance, Merck Sharp & Dohme Ltd., UK

Programme CommitteeBarbara de BernardiDeputy EU QPPV, Pfizer Inc., Italy

Peter De VeeneDeputy EU QPPV, F. Hoffmann-La Roche Ltd., Switzerland

Brian edwardsPrincipal Consultant Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., UK

Vicki Page ClarkHead of Pharmacovigilance, QPPV, Archimedes Pharma, UK

Valerie simmonsLilly QPPV, Global Patient Safety, Eli Lilly and Company Ltd., UK

OverviewThis is the 5th European Forum for Qualified Person for Pharmacovigilance (QPPV). The role of the QPPV continues to be an important one. In an ever changing regulatory environment it is vital to remain abreast of any areas likely to impact on this role. Such changes may arise from updates to European requirements or those of the regulatory authorities outside of the EEA (e.g. FDA) or from cross-regional initiatives such as ICH. The next 18 months will present a real challenge to QPPVs as significant changes to European pharmacovigilance legislation will be implemented in July 2012, changes to FDA legislation are pending, and two ICH initiatives will require implementation. This meeting aims to inform QPPVs on these forthcoming challenges, provide perspectives on implementation whilst also recognising that the challenges of day to day QPPV responsibilities still have to be met.

Objectives• To provide insight into the new EU pharmacovigilance legislation and to better understand the likely

impact on the role of QPPV• To look at the progress of other ongoing initiatives from a QPPV perspective e.g. Risk Managements

Plans (RMPs) and REMS, and to explore future CIOMS and ICH projects• To further discuss a question raised at last year’s meeting – ‘How does the role of the QPPV impact

patient safety?’• To explore the involvement of QPPV in clinical trials and pre-authorisation labelling • To understand the challenges of QPPV role in small and non-innovator companies• To understand the current topics of focus in pharmacovigilance inspections which impact on QPPV

oversight• To provide some practical guidance to QPPVs on coping with the reality of the day to day work of the

QPPV

Who Will Attend • European Qualified Persons for Pharmacovigilance• Deputy Qualified Persons• Senior Pharmacovigilance Regulators and Inspectors• CRO and Consultants providing QPPV Services• National Responsible Persons for Pharmacovigilance

Continuing EducationDIA meetings are generally approved by the SwAPP (Swiss Association of Pharmaceutical Professionals) Commission for Professional Development (CPD) and SGPM (Swiss Society of Pharmaceutical Medicine) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available on request from the registration desk

FiNaL Programme

PreseNtatioNs aVaiLaBLe oNLiNeYou should have received an email from diaeurope@diaeurope.org with instructions on how to download presentations on Thursday, 5 May 2011.

Please note: If you cannot find a presentation online, it is because:•ThepresenterdidnotyetprovideDIAEurope

with a slide presentation to upload•Thepresenterdidnotagreetosharethe

presentation with meeting attendees•Youhavenotpaidtheregistrationfee

Registered participants will be able to download the updated presentations after the conference. DIA Europe will send you an email with instructions on how to access presentations on Wednesday, 18 May 2011.

CertiFiCate oF atteNDaNCePick up your Certificate of Attendance!

The DIA Europe Team will have your Certificate of Attendance available onsite at the Registration Desk from Thursday, 12 May 2011.If you would like to receive your certificate after the conference please call us on +41 61 225 51 51

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Tuesday | 10 May 2011

EU QPPV PrE-conFErEncE workshoP

12:30 registratioN aND WeLCome CoFFee

13:00 sessioN 1hoW to Be aN eU QPPV: What YoU NeeD to kNoW aND What’s NeW Session Chairperson:Janet hormbrey, Executive Director, EU Qualified Person for Risk Management & Pharmacovigilance, Merck Sharp & Dohme Inc., Belgium

Speakers:Elspeth McIntosh, Director Castle Pharmacovigilance Limited, UKKeith Wibley, Director, Pharmacovigilance NDA Regulatory Science Ltd, UK

This session will focus on ensuring a comprehensive understanding of the role of the EU QPPV and is aimed at those EU QPPVs who are new to the role, or are experiencing challenges with some aspect of the role. It is also ideal for people who support the EU QPPV or who are thinking of taking on a QPPV role. It will discuss the requirements of the QPPV role, the responsibilities of both the Marketing Authorisation Holder (MAH) and the EU QPPV, advise on the practicalities of managing these responsibilities and of maintaining compliance in a range of company types. It will also include an update on the impact of the new EU pharmaceutical legislation on the QPPV role.

15:30 CoFFee Break

11:00 sessioN 2sPeCiaL toPiCs For the eU QPPVSession Chairperson: Deidre mcCarthy, Director, Lifecycle Safety, Quintiles Ireland Limited, Ireland

Building on the first part of today’s course, these three presentations will be devoted to specific topics relevant to the role of the EU QPPV. An interactive panel discussion will conclude the course, and will provide an opportunity for new QPPVs to ask questions about anything they have learned during the day.

Legal aspects related to the role of the eU QPPVChris Foreman, Director, Legal Affairs, Scandinavia Region, Merck Sharp & Dohme Inc., Belgium

The QPPV has personal legal responsibility for the compliant functioning of the pharmacovigilance system. In this session you will learn about the legal considerations that every QPPV (and their company’s management) needs to be aware of and hear from expert legal counsel about potential pitfalls and solutions, as well as discuss the recommended content and need for QPPV contracts.

Job Descriptions and eU QPPV standard operating Procedures: What do you need and what should they cover?Elspeth McIntosh, Director Castle Pharmacovigilance Limited, UK Janet Hormbrey, Executive Director, EU Qualified Person for Risk Management & Pharmacovigilance, Merck Sharp & Dohme Inc., Belgium

The activities of the QPPV are many and varied. What documentation should exist to describe how you execute these roles and responsibilities in your company, and how you delegate activities? In this session we will examine practical approaches and regulatory expectations regarding the QPPV Job Description and SOP(s) in different types of companies.

the role of the eU QPPV in inspections and Preparing for inspectionsKeith Wibley, Director of Pharmacovigilance, NDA Regulatory Science Ltd, UK

Pharmacovigilance inspections are a fact of life for every QPPV. In this session former MHRA pharmacovigilance inspector will guide you through the pivotal role of the QPPV in regulatory inspections, including what to focus on when preparing for the inspectors’ visit.

Panel Discussion including today’s speakers plus Jean-Paul Dutertre and Conxita Barajas representing small and medium sized companies.

18:00 eND oF WorkshoP

Wednesday | 11 May 2011

start oF QPPV conFErEncE

08:00 registratioN aND WeLCome CoFFee

08:30 sessioN 1FUtUre eU LegisLatioN aND gUiDaNCe – imPLemeNtatioN aND imPaCtSession Chairperson: Peter arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU

In the next 18 months, the most significant changes to the European pharmacovigilance legal framework since 1995 will need to be implemented through new implementing and good PV Practice guidances. This will have inevitable consequences for all parties involved, including the European Agency, National Competent Authorities, and Marketing Authorisation Holders. For QPPV’s, the impact may well be oversight of a PV system which looks very different to the current model. This session will examine from an EMA and industry perspective what the future could hold.

industry PerspectiveBalwant Heer, EU QPPV, Mylan, UK

agency PerspectivePeter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU

Panel Discussionwith session speakers

10:30 CoFFee Break

11:00 sessioN 2CUrreNt reQUiremeNt UPDatesSession Chairperson: Brian edwards, Principal Consultant Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., UK

For the QPPV, pharmacovigilance means more than just Volume 9A. It means understanding how risk management should be implemented, what available tools are there and how should new resources such as ENCePP be applied. This session will present the latest thinking in these areas as well as looking at a particularly challenging example: How to manage the safety of biosimilars.

Benefit-risk management system and its anticipated impact on the QPPV roleJan Petracek, CEO, European PharmInvent Services s.r.o., Czech Republic

safety of Biosimilars: What a QPPV should know?Sandy Eisen, Previously Chief Medical Officer, Teva Pharmaceuticals Europe Ltd., UK

Panel Discussion – hot topicswith session speakers

12:30 LUNCh

14:00 sessioN 3NoN-eU reQUiremeNts aND imPaCt oN QPPV aCtiVitiesSession Chairperson: Peter De Veene, Deputy EU QPPV, F. Hoffmann-La Roche Ltd., Switzerland

Although the role of the Qualified Person responsible for Pharmacovigilance is mandated by the European legislation, the QPPV is held responsible for the establishment and the maintenance of the pharmacovigilance system which oftentimes means the ‘global’ pharmacovigilance system. Therefore, it is important that the QPPV plays an active role in identifying non-EU requirements which may have an impact on the global pharmacovigilance system to ensure continued compliance with global regulations. In addition, QPPVs should be involved in the thought-shaping initiatives such as CIOMS and ICH. This session will highlight some of the new and upcoming non-EU regulations and initiatives that will influence pharmacovigilance in the future.

FDa and the New iND regulationsPeter De Veene, Deputy EU QPPV, F. Hoffmann-La Roche Ltd., Switzerland

Changes on the horizon: Cioms iX iCh upcoming initiativesValerie Simmons, Lilly QPPV, Global Patient Safety, Eli Lilly and Company Ltd., UK

impact of Japanese PV environment on QPPV activityYoshiakiOhashi,Ph.D.,DepartmentManager,DrugSafetyCoordinationDept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan

15:30 CoFFee Break

16:00 sessioN 4the VaLUe oF the QPPVSession Chairperson: Vicki edwards, Senior Director, European Pharmacovigilance, Abbott Laboratories, UK

During last year’s QPPV Forum a delegate related how his Senior Management had asked the question: ‘How does the QPPV impact on patient safety?’. This session will explore this question further.

What is the value of the QPPV to the patient? Philippe Van der Auwera, Global Head of Safety Risk Management (PDS) & EU-QPPV, F. Hoffmann-La Roche Ltd., SwitzerlandElisabeth Swain, Director, Pharmacovigilance Advocacy and Policy, GlaxoSmithKline, UK

Patient’s Perspective David Head, Chief Executive, RP Fighting Blindness, United Kingdom

17:30 DriNks reCePtioN

18:30 eND oF DaY oNe

Thursday | 12 May 2011

09.00 sessioN 5QPPV & Pre-aUthorisatioN aCtiVitiesSession Chairperson: Barbara de Bernardi, Deputy EU QPPV, Pfizer Inc., Italy

Regulatory expectations with respect to the QPPV responsibilities focus on post-authorisation pharmacovigilance. However, some activities typical of the pre-authorisation phase of a medicinal product may require the QPPV oversight and input.This session will offer an overview of requirements, principles, relevant methodologies and general implications regarding GCP inspections, DSURs and Labeling. Moreover, it will provide considerations on an early involvement of the QPPV in inherent tasks.

gCP inspections and Pharmacovigilance Patricia Moore, Senior Pharmacovigilance Inspector, MHRA, UK

DsUr (e2F): the role of the QPPV, practical implications and when to involve the QPPVBarry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca, United Kingdom

Labeling activities: role of the QPPVBarbara de Bernardi, Deputy EU QPPV, Pfizer Inc., Italy

10:30 CoFFee Break

11:00 sessioN 6CoNtiNUiNg iNsPeCtioN themes: Where is QPPV oVersight NeeDeD?Session Chairperson: Patricia moore, Senior Pharmacovigilance Inspector, MHRA, UK

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Inspections are always of primary interest for QPPVs – this session will explore the current topics of interest.

QPPV governance and oversight: Local versus eU QPPV & affiliate oversight and patient support programmes Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany

iCsr Quality review: Use of ‘always serious’ lists and invalid cases Vicki Edwards, Senior Director, European Pharmacovigilance, Abbott Laboratories, UK

regulatory aspects of Pharmacovigilance inspections Calvin Johnson, Senior Pharmacovigilance Inspector, MHRA, UK

12:30 LUNCh

14:00 sessioN 7PraCtiCaL issUes aFFeCtiNg the DaY to DaY Work oF the QPPV – With FoCUs oN iNFLUeNCeSession Chairperson: margaret Walters, Director, EU Pharmacovigilance, Merck Sharp & Dohme Ltd., UK

The day-to-day workload of EU QPPV varies considerably, not only depending on the size and complexity of the MAH they represent, but also more fluid factors factors such as the number of products with ‘active’ safety issues and the degree to which each QPPV is ‘hands-on’ versus ‘in oversight’. This session will present situations where QPPVs need to utilise influencing, plus explore techniques by which such skills can be enhanced to maximise effectiveness.

introductionOpening remarks to approach the topic, facilitated by Margaret Walters

keynote presentation SteveJ.Martin,Co-AuthorofthebestsellerYES!andDirector,InfluenceatWork, UK

Panel DiscussionWith Steve J. Martin, Margaret Walters and Vicki Edwards

All attendees are invited to do the online quiz on www.scienceofyes.com in advance to prepare for this session. Please submit your specific questions that you would like to ask the panellists to michael.hediger@diaeurope.org

15:30 CoFFee Break

16:00 sessioN 8QPPVs iN smaLL aND/or NoN-iNNoVator ComPaNiesSession Chairperson: Vicki Page Clark, Head of Pharmacovigilance, QPPV, Archimedes Pharma, UK

QPPVs for Small and Medium Enterprises (SMEs) and non-innovator companies may often face particular challenges, such as resource concerns and how to handle legislation changes without the support of multiple affiliate offices. This session will present some situations where QPPVs may come up against such issues and will offer some considerations of how a QPPV might deal with these.

risk management plans for well established products with more ma holders - the issues and implementationWendy Huisman, EU Qualified Person for Pharmacovigilance, Teva Pharmaceuticals Europe B.V., The Netherlands

the new PV legislation: what does it mean to a sme operating across multiple countries? John Barber, Director, Head of Pharmacovigilance - European Operations, Dr. Reddy’s Laboratories, UK

Challenges with resourcing and when being the QPPV is not your only roleJanet Green, EU Qualified Person for Pharmacovigilance, Sepracor Pharmaceutical Ltd., Ireland

17:15 WraP UP aND eND oF CoNFereNCe

Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of

the organisation they represent, or that of the DIA.

Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media,

is prohibited without prior written consent from DIA.

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Register for upcoming DIA conferences in Europe

For more information and a complete listing of all DIa conferences, please visit www.diahome.org > click on conferences / Meetingscall the DIa in Europe on +41 61 225 51 51 or email: diaeurope@diaeurope.org

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5th annual clinical Forum10-12 October 2011 | Basel, Switzerland I ID 11103

2nd Joint DIa/EMa statistics workshop26-28 October 2011 I London, UK I ID 11107

Influence of the EU Legislation on the Bulgarian Drug Industry Free workshop for delegates from Bulgaria / CEE countries! - Organised by the DIA Advisory Council of Europe

26 May 2011 I Sofia, Bulgaria I ID 11119

Quality risk Management in clinical Drug Development conference27-28 October 2011 I Berlin, Germany I ID 11113

European cardiac safety conference3-4 November 2011 I Barcelona, Spain I ID 11112

Joint DIa/EMa/FDa orphan Drug Designation workshop10-11 November 2011 I London, UK | ID 11120

Joint DIa/Mhra advanced therapy Medicinal Products workshop18 November 2011 I London, UK I ID 11111

12th conference on European Electronic Document Management (eDM)30 November – 2 December 2011 I Zurich, Switzerland I ID 11104

24th annual EuroMeeting26-28 March 2012 | Copenhagen, Denmark | ID 12101

2nd Joint DIa/EMa EncePP Information Day7 November 2011 I London, UK I ID 11118