DIA
Drug Information Association Logo

8th European Forum for Qualified Person for Pharmacovigilance (QPPV) and Pre-conference Workshop

May 14 2014 9:00AM - May 15 2014 5:30PM | Millennium Gloucester Hotel London Kensington 4-18 Harrington Gardens London SW7 4LH United Kingdom

« Back to Listing

Overview 

Please note that the Pre-Conference Workshop is SOLD OUT! There is a waiting list available. For more information contact diaeurope@diaeurope.org. 

It is now nearly two years since the implementation of the new EU PV legislation, and so it is time to reflect on the impact these changes have had on the role of the QPPV and their position and relationship with Marketing Authorisation Holders and regulatory agencies. QPPVs face multiple challenges, and the 2014 meeting will provide insights from regulators as well as MAH management into the expectations these stakeholders have of the QPPV.

In addition, Good PV Guidelines are still evolving. Therefore it is vital to remain abreast of any changes likely to impact the QPPV’s essential role. Such changes may arise from updates to European requirements or outputs from evolving projects. However, how the QPPV operates is also influenced by regulatory authorities outside of the EEA (e.g. FDA) and from cross-regional initiatives such as ICH. The 2014 meeting aims to inform QPPVs about any challenges relating to the ongoing release of the new PV legislation by the EMA, alert them to what is coming down the pipe and provide recommendations on preparing and incorporating these changes into the daily life of the QPPV.

Session Topics Include:

  • Two years later – Impact of the new EU PV requirements on the QPPV role
  • Risk Minimisation – Medication beliefs and behaviours, EU requirements
  • Metrics and KPIs – Support for QPPV oversight
  • Networks and Communication – Sources of information for QPPVs
  • Being a QPPV in Different Environments (non- EU companies, contract QPPVs etc.)
  • Quality Systems – Compliance with GVP Module 1
  • PV Inspections – What’s new and what’s old (but still being found…)
  • Operational Challenges; e.g. the PSMF, in place and meeting Regulator needs?

Who Should Attend 

  • EEA Qualified Persons for Pharmacovigilance
  • Deputy Qualified Persons for Pharmacovigilance
  • Senior Pharmacovigilance Regulators and Inspectors
  • CRO and Consultants providing QPPV Services
  • National Responsible Persons for Pharmacovigilance
  • Quality Management
  • Heads of Pharmacovigilance

Learning Objectives 

  • Identify the expanded expectations of the role in the context of the new regulatory framework and transparency initiatives
  • Examine current areas of real challenges for the QPPV such as mergers, outsourcing, complex marketing situations and post-authorisation safety studies
  • Advance understanding of the legal aspects and associated liabilities for the QPPV
  • Learn of regulatory and inspectorate expectations of the QPPV
  • Share experiences to better understand how to fulfil and cope with the role of the QPPV

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

The QPPV Forum has been awarded with 15 CPD credits from the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians (RCP) of the UK. Medical practitioners who are eligible for credits can click on http://www.fpm.org.uk/cpd/registration for more information. If you are already a CPD member, please go directly to http://cpd.fpm.org.uk to claim your credits. Certificates are available on request from the DIA registration desk.

Hotel & Travel 

Millennium Gloucester Hotel London Kensington
A limited number of rooms are available at a special rate. DIA rate is guaranteed until 31st March 2014, or until room block is filled. Attendees should make reservations as soon as possible.

To make your booking, go to www.millenniumhotels.co.uk/millenniumgloucester/
Booking Code: LOND130514 (insert the code into the Enter Code box)
Single GBP 145.00/Double GBP 155.00 including breakfast and VAT

Address: 4-18 Harrington Gardens, London SW7 4LH, UK
Tel:  +44(0) 207 331 6105 Fax: +44(0) 207 331 6123

Travel Information
For details on public transport please visit http://www.tfl.gov.uk

Contact Information 

DIA Europe
Kuchengasse 16
4051 Basel, Switzerland
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Email: DIAEurope@diaeurope.org

Program Committee 

Previous Next

Agenda  

Tutorials Tuesday, May 13, 2014

  • 1:00PM - 5:30PM

    Room: Kensington Suite

    EU QPPV Pre-Conference Workshop

    As a result of feedback from previous years we are repeating this workshop aimed at those EU QPPVs who are new to the role, those who support the QPPV and those who are thinking of taking on a QPPV role. It can also act as a check-up for those who need it. The session will focus on providing an understanding of the QPPV role, the practical issues facing QPPVs in a range of company sizes and types, what skills and knowledge you need for the role, and legal considerations for QPPVs.

    Click on View PDF to download programme details.

Day 1 Wednesday, May 14, 2014

  • 9:00AM - 11:00AM

    Session 1: Developing Areas – Risk Management and Minimisation


    Session Chair(s):

    • Peter De Veene, MD
      EU QPPV
      Roche Products Ltd, United Kingdom

    Risk management and mitigation is a rapidly evolving area. Risk management plans have been around for many years and contain the important identified and potential risk for a given product and how the MAH proposes to manage these risks to optimise the benefit for the patients. In recent months, the EMA published the final guideline on measuring effectiveness of risk minimisation activities. As it is also important in the risk management cycle to continuously quantify the risk and communicate risks appropriately to the public, this session will also explore these elements of risk management and mitigation.

    Speaker(s):

    • Where are we now?
      Corinne de Vries
      Head of Risk Management Review (ad interim)
      European Medicines Agency, United Kingdom
    • Medication-Related Beliefs and Behaviour: Bridging the information-action gap
      Robert Horne
      Professor of Behavioural Medicine
      School of Pharmacy, University College London, United Kingdom
    • Observational Medical Outcomes Partnership (OMOP)
      Martijn Schuemie, PhD
      Associate Director, Epidemiology Analytics
      Janssen Research and Development, United States
  • 11:30AM - 1:00PM

    Hot topics


    Session Chair(s):

    • Margaret Anne Walters
      Director, EU PV and DQPPV
      Merck Sharp & Dohme Ltd, United Kingdom

    Hot topics

    Speaker(s):

    • Post-Authorisation Efficacy Studies (PAES)
      Nadia Foskett
      Principal Epidemiologist, CNS
      Roche Products Limited, United Kingdom
    • Updates on Signal Detection
      Phil Tregunno
      Signal Management Unit Manager
      MHRA, United Kingdom
    • Progress with Risk Management Lay Summaries
      D.K.Theo Raynor, PhD, MPharm
      Professor of Pharmacy Practice
      University of Leeds, United Kingdom
  • 2:30PM - 4:00PM

    Session 3: Have the new EU PV regulations changed the role of the QPPV? Two years on – how different is the role? Regulator’s view


    Session Chair(s):

    • Doris Irene Stenver, MD, MPA
      Chief Medical Officer
      Danish Health and Medicines Authority, Denmark

    The pharmacovigilance legislation, which came into force in 2012, is highly innovative. The new legislative framework paved the way for significant changes in how we perform and organise Pharmacovigilance in the EU network. One major aim of the new legislation has been to clarify the roles and responsibilities of different stakeholders. This session will focus on how and to which extent the legislation has changed the role of the QPPV. Three different perspectives will be presented – expectations of the PRAC and of a national regulatory authority to the QPPV, followed by an inspectors view.

    Speaker(s):

    • PRAC expectations of QPPV
      Sabine Straus, MD
      Head of Pharmacovigilance
      Medicines Evaluation Board (MEB), Netherlands
    • Regulators’ View
      Viola Macolic Sarinic, DrSc, MD, MSc
      Head of Agency
      Agency For Medicinal Products & Med. Devices (HALMED), Croatia (Hrvatska)
    • Inspectors’ View
      Kimberley Sherwood, DrSc
      Pharmacovigilance Inspector
      Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany
  • 4:30PM - 6:00PM

    Session 4: Has the new EU PV regulations changed the role of the QPPV? 2 years’ on – how different is the role? Industry View


    Session Chair(s):

    • Michael Richardson, MD, FFPM
      International Head GPV&E and EU QPPV
      Bristol-Myers Squibb, United Kingdom

    The new PV legislation which came into effect mid 2012 changed the drug safety environment in its scope and impact on reporting and evaluating information. Safety came to the centre of benefit risk and the role of the safety function with it. How did this impact the role of the QPPV within MAHs and externally with agencies? We will hear from regulators in session 3 and in this session from an industry perspective.

    Speaker(s):

    • Industry Senior Management’s View
      Rick Lilley, PhD
      Vice President, Global Regulatory Affairs
      UCB, S.A., Belgium
    • Industry QPPV View
      Elspeth McIntosh
      Director
      Castle Pharmacovigilance Ltd, United Kingdom

Day 2 Thursday, May 15, 2014

  • 9:00AM - 10:30AM

    Session 5: Networking and Communications


    Session Chair(s):

    • Vicki Edwards
      QPPV and Head of Affiliate Vigilance Excellence
      Abbvie Ltd., United Kingdom

    This session will explore the importance of appropriate networking and communication to the success of a QPPV. We will hear about how a new QPPV established his communication networks and the value he places on them. We will also look at the role of QPPV through the lens of a journalist and examine how the public may see the role. The session will also explore current approaches to communication with HCPs, patients and consumers and look at how the QPPV should be involved.

    Speaker(s):

    • QPPV networking – Formal versus informal, DIA, EFPIA, Facebook
      Logesvaran Yogendran
      Vice President, QPPV Pharma
      Johnson & Johnson, United Kingdom
    • Communication with HCP, Patients and Consumers
      Juan Garcia Burgos
      Scientific Administrator
      European Medicines Agency, United Kingdom
    • The QPPV in the Eyes of the Press, the Patients and the Public
      Faraz Kermani
      Senior Editor Europe
      The Pink Sheet, United Kingdom
  • 11:00AM - 12:30PM

    Session 6: Operating as a QPPV in Different Companies


    Session Chair(s):

    • Natalia Kocankova, MD, MBA
      Director, Drug Safety Europe
      Sucampo AG, Switzerland

    The scope of the role of EU QPPV is clearly defined in the EU legislation. In this session you will have the opportunity to learn how roles and priorities of EU QPPVs may differ in different types of companies and different cultural environments. The session will convey practical experience of EU QPPVs providing services for contract and small companies; you will learn what the daily challenges for EU QPPVs from generics companies are, and you will get an overview of the role of EU QPPV focusing on cultural differences.

    Speaker(s):

    • Japanese Perspective – Cultural differences
      Kees Bart Teeuw, PhD
      Vice President Drug Safety & Pharmacovigilance
      Astellas Pharma Europe, Netherlands
    • Contract and Small Company QPPVs
      Elspeth McIntosh
      Director
      Castle Pharmacovigilance Ltd, United Kingdom
    • Generics – Challenges in meeting requirements for: RMPs, PASS, CCSI, Product transfers & Mergers
      Balwant Heer
      VP, Global Head Product Safety & Risk Management, EEA QPPV
      Mylan Inc., United Kingdom
  • 2:00PM - 3:30PM

    Session 7: Operational Challenges


    Session Chair(s):

    • Margaret Anne Walters
      Director, EU PV and DQPPV
      Merck Sharp & Dohme Ltd, United Kingdom

    Although the degree of EU QPPV involvement in operational aspects varies according to company set-up, it is important to be at least aware of input on areas of practical challenge or interpretation in case of lack of regulatory clarity. Many long-term QPPVs are fond of saying “the devil is in the detail”. This session will aim to highlight such areas detected internally or via inspections, and examples of QPPV/MAH solutions towards maintaining compliance.

    Speaker(s):

    • Handling Uncertainties and Observed Solutions in Practise
      Christine H. Bendall
      Consultant & Director
      Pharview Ltd, United Kingdom
    • Progress with Centralisation: Centralised reporting, literature screening, PSUR repository
      Margaret Anne Walters
      Director, EU PV and DQPPV
      Merck Sharp & Dohme Ltd, United Kingdom
    • Operational Matters
      Peter De Veene, MD
      EU QPPV
      Roche Products Ltd, United Kingdom
  • 4:00PM - 5:30PM

    Session 8: Quality: The never ending story?


    Session Chair(s):

    • Brian Edwards, MD, MRCP
      Principal Consultant, Pharmacovigilance and Drug Safety
      NDA Regulatory Science Ltd, United Kingdom

    President Harry Truman once said “The buck stops here”'. And so it is with the EU QPPV who shall have sufficient authority to influence the performance of PV activities and the quality systems and to promote, maintain and improve compliance with the legal requirements of the MAH. What do we understand by ‘quality systems’ let alone how can we ‘influence’ and’ improve’ them? In this session we will examine latest thinking, best practices, the scope for interactions with QA organisations and give practical guidance for QPPVs to implement when they return back to their companies.

    Speaker(s):

    • Results of a Bench Mark on Safety Variations
      Gro Laier, MD
      Deputy QPPV
      Novo Nordisk A/S, Denmark
    • Two views to Complying with Module 1 - QA view (outside looking in)
      Pam Bones, PhD
      Head, Global Regulatory Quality-PV
      Allergan, Inc., United Kingdom
    • Two views to Complying with Module 1 - PV view (inside looking out)
      Noha Kassem, PhD
      Senior Director of Quality in Global Patient Safety
      Eli Lilly & Company Ltd., United Kingdom
    • Quality Management in Regulatory Affairs: What should the QPPV know?
      Nick Sykes, MS
      Senior Director, Worldwide Safety & Regulatory
      Pfizer Inc., United Kingdom

Exhibits  

DIA is not offering exhibition for this meeting. For more information on exhibition opportunities in 2014 please contact: Roxann Schumacher, DIA Exhibits Manager on +41 61 225 51 38 or email: roxann.schumacher@diaeurope.org

Registration Fees 

Member

Member Academia
€710.00
Member Government
€710.00
One Day Rate Member Academia
€425.00
One Day Rate Member Government
€425.00
One Day Rate Member Industry
€850.00

Non-Member

NonMember Academia
€840.00
NonMember Government
€840.00
NonMember Standard
€1550.00
One Day Rate NonMember Government
€555.00
One Day Rate NonMember Industry
€980.00
One Day Rate NonMemberAcademia
€555.00
Registration Fees for Additional Offerings
FULL- EU QPPV Pre-Conference Workshop - Member Standard Rate
€400.00
FULL- EU QPPV Pre-Conference Workshop - Standard Rate
€400.00
Group Discounts

Group Discounts Available – Send 3 participants and the 4th is free!

Conditions apply. Online registration not available for group discounts. Call DIA in Europe on +41 61 225 51 51 or email for further information.

Register Online
« Back to Listing Back To Top