Drug Information Association Logo
Corporate Tagline

7th European Forum for Qualified Person for Pharmacovigilance (QPPV) 17-18 April 2013; Pre-conference Workshop 16 April 2013

Apr 17 2013 8:00AM - Apr 18 2013 5:00PM | Holiday Inn Bloomsbury Coram Street London WC1N 1HT United Kingdom

« Back to Listing

Overview 

In an ever changing regulatory environment it is vital to remain abreast of any changes likely to impact on the QPPV’s essential 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 2013 meeting aims to inform QPPVs about any challenges relating to the ongoing release of the new PV legislation by the EMA and provide recommendations on incorporating those changes into the daily life of the QPPV.

Mobile App available for registered participants!
Go to your PlayStore or AppStore and search for "DIA QPPV" to download the app, sign in with your email address (the email address you registered with) and see all the information on your device.

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 

  • To explore early experience and challenges of implementation of the new Pharmacovigilance legislation
  • To identify and understand the specific impact of the changes on the QPPV role
  • To address issues arising for QPPVs in working with partners
  • To provide some practical guidance on how to work with the new Pharmacovigilance System Master File
  • To determine if the QPPV now needs new skills
  • To understand the role of the QPPV in the world of ongoing benefit/risk evaluation

Hotel & Travel 

Hotel Holiday Inn Bloomsbury
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until 1st March 2013, or until room block is filled). Attendees should make reservations as soon as possible.

Standard Room Rates
£165.00 per room , inclusive of full english breakfast and VAT. Please note that rates may change according to the prevailing VAT rate at the time of payment. 

Please call the reception on +44 871 942 9222 and quote the reservation number/group code:  MJJ

Address: Coram Street, London WC1N 1HT, UK
Phone: 0800 561 057
Website: http://www.holidayinn.co.uk/bloomsbury

 

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

Contact Information 

DIA Europe
Kuchengasse 16, Postfach
4002 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, April 16, 2013

  • 1:00PM - 6:00PM

    EU QPPV Pre-Conference Workshop

    As a result of positive feedback from previous years we are repeating this informative workshop. It is intended for 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. The workshop 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.

Day 1 Wednesday, April 17, 2013

  • 9:00AM - 10:30AM

    Reflections on the New Legislation; is it meeting the objectives?


    Session Chair(s):

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

    Speaker(s):

    • Are Patients Better Protected? – An industry view
      Thomas Loenngren
      Strategic Advisor
      NDA Regulatory Science Ltd, United Kingdom
    • Was the Pain Worth the Gain?
      Barry Arnold, MD
      EU Qualified Person for Pharmacovigilance
      AstraZeneca, United Kingdom
    • And what do patients think?
      David Haerry
      Member of Board of Directors
      European AIDS Treatment Group, Belgium
  • 11:00AM - 12:30PM

    Pharmacovigilance Risk Assessment Committee and the QPPV


    Session Chair(s):

    • Maarten Lagendijk, MSc
      Pharmacovigilance Coordinator
      MEB, Netherlands

    Speaker(s):

    • PRAC: Experiences to date
      Almath Spooner
      Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
      IMB, Ireland
    • Signal Detection under the New Legislation
      Anja Van Haren, MSc
      EurdraVigilance Coordinator
      MEB, Netherlands
    • PRAC/Industry communication challenges
      Peter De Veene, MD
      EU QPPV
      Roche Products Ltd, United Kingdom
  • 2:00PM - 3:30PM

    EU legislation impact on global requirements & QPPV oversight


    Session Chair(s):

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

    Speaker(s):

    • Personal Perspectives on Practicality of Being a QPPV in a Global System
      Sue Rees, MS
      Eisai Europe Ltd, United Kingdom
    • Benefit/Risk for the PBRER of Mature Products - Is this a waste of our time or an opportunity?
      Anne-Ruth Van Troostenburg De Bruyn
      tGP MD(Lond) FFPM
      EBDLondon, United Kingdom
    • Risk Management: Company standards versus local requirements
      Michael Richardson, MD,FFPM
      International Head GPV&E and EU QPPV
      Bristol-Myers Squibb, United Kingdom
  • 4:00PM - 5:30PM

    Contracts and Agreements: How can the QPPV achieve oversight ?


    Session Chair(s):

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

    Speaker(s):

    • License Partner Oversight, Towards a Comprehensive Approach
      Philip J. Weatherill
      Director, Global Pharmacovigilance
      Ipsen Biopharm Ltd., United Kingdom
    • Challenges with Updating Agreements through Product Lifecycles and With Changing Expectations
      Gro Laier, MD
      Deputy QPPV
      Novo Nordisk A/S, Denmark
    • Auditing for Compliance and/or Sharing PSMF and Inspection Data – The future?
      Pam Bones
      Head, GRO-PV Audit
      Allergan Ltd., United Kingdom

Day 2 Thursday, April 18, 2013

  • 9:00AM - 11:00AM

    From Safety Signal to B/R Assessment : Impacts on PSURs/PBRERs and RMPS


    Session Chair(s):

    • Barbara De Bernardi, MD
      EU QPPV Deputy
      Pfizer Italia S.r.l., Italy

    Speaker(s):

    • Signal Management - Signal detection, validation/evaluation - Risk determination for New EU-RMPs
      Craig Hartford, MD,PhD,MSc
      VP, Safety Surv & Risk Management, Worldwide Safety Strategy, W R&D.
      Pfizer Ltd, United Kingdom
    • From PSURs to PBRERs - Focus on special challenges (e.g. off label use, effectiveness, transparency) - PRAC Interactions/ experiences
      Valerie E. Simmons, MD,FFPM
      EU QPPV, Global Patient Safety
      Eli Lilly and Company Ltd, United Kingdom
    • PASS and ENCePP Register
      Susana Perez-Gutthann, MD,PhD,MPH,FISPE,FRCP
      VP, Head Epidemiology
      RTI Health Solutions, Spain
  • 11:30AM - 12:30PM

    New Skills for the QPPV


    Session Chair(s):

    • Elspeth McIntosh
      Director
      Castle Pharmacovigilance Ltd, United Kingdom

    Speaker(s):

    • Technical Challenges – What’s next for EVMPD and E2B
      Adrian Maynier
      PV Business Systems Specialist
      Genzyme Europe B.V, Netherlands
    • External Communications – New skills and challenges arising from increased transparency
      Peter Coe
      Director
      Tudor Reilly, United Kingdom
  • 1:30PM - 2:30PM

    Are There Different Expectations of the QPPV at Inspections Under the new Legislation ?


    Session Chair(s):

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

    Speaker(s):

    • My First PV Inspection under the New Legislation
      Vicki Edwards
      QPPV and Head of Affiliate Vigilance Excellence
      abbvie Ltd., United Kingdom
    • Inspection under the New Legislation – How is the industry doing?
      Anya Sookoo, PhD
      Expert Inspector, GCP and Pharmacovigilance
      MHRA, United Kingdom
  • 3:00PM - 5:00PM

    PSMF – Creation , maintenance and QPPV involvement


    Session Chair(s):

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

    Speaker(s):

    • Setting the Scene – The need for a PSMF
      Wendy Huisman, PharmD
      EU Qualified Person for Pharmacovigilance
      Teva Pharmaceuticals Europe B.V., Netherlands
    • Questionnaire Feedback and Panel Discussion
      Peter De Veene, MD
      EU QPPV
      Roche Products Ltd, United Kingdom
    • Christine H. Bendall
      Consultant & Director
      Pharview Ltd, United Kingdom

Exhibits  

DIA is not offering exhibition for this meeting. For more information on exhibition opportunities in 2013 please contact: Roxann Schumacher, DIA Exhibits Manager on +41 61 225 51 38 or email: roxann.schumacher@diaeurope.org

Registration Fees 

Member

Member Academia
€683.00
Member Government
€683.00
Member Standard
€1365.00
One Day Rate Member Academia
€410.00
One Day Rate Member Government
€410.00
One Day Rate Member Industry
€819.00

Non-Member

NonMember Academia
€798.00
NonMember Government
€798.00
NonMember Standard
€1480.00
One Day Rate NonMember Academia
€525.00
One Day Rate NonMember Government
€525.00
One Day Rate NonMember Industry
€934.00
Registration Fees for Additional Offerings
EU QPPV Pre-Conference Workshop - Member Standard Rate
€300.00
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

CANCELLATION POLICY: All cancellations must be made in writing and be received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

« Back to Listing Back To Top