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8th EGA Pharmacovigilance Discussion Forum
21 January 2015
Radisson Blu Portman Hotel
22 Portman Square, London W1H 7BG, UK
Wednesday 21 January 2015
08:00
Registration and welcome coffee
09:00
Opening address  Maarten Van Baelen, Medical Affairs / Market Access Director,
EGA
09:05
Session 1 – The implementation of the EU pharmacovigilance legislation
Chair  Wendy Huisman, EU Qualified Person for Pharmacovigilance, Teva Europe, NL,
Chair of EGA Pharmacovigilance & Drug Safety Working Group and EudraVigilance
Expert Working Group Member
Two and a half years of operation  Peter Arlett, Head of Pharmacovigilance
Department, EMA, EU
Two and a half years of operation of the Pharmacovigilance Risk Assessment
Committee  June Raine, PRAC Chair, Director of Vigilance and Risk Management of
Medicines, MHRA
10:00
Questions & answers
Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE)
 Paul Barrow, Head of Special Projects of the Vigilance Intelligence and Research
Group, MHRA
Social media, the future of ADR reporting and privacy policies  Mick Foy, Group
Manager, Vigilance Intelligence and Research Group Vigilance and Risk Management of
Medicines, MHRA
Panel discussion with session speakers and interaction with the floor on achieving
harmonisation of implementation
11:15
Networking coffee break
11:45
Session 2 – Improving Risk Management Plans
Chair  Sebastian Horn, Head Global Pharmacovigilance & Clinical Safety, EU/EEA
QPPV, Sandoz International GmbH
RMPs: the generic medicines industry’s experiences  John Barber, QPPV and Head
of Pharmacovigilance, Dr. Reddy’s Laboratories Europe
EMA views on RMPs  Luis Prieto, Risk Management Specialist, EMA
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209
12:40
Questions & answers and discussion
13:00
Networking buffet lunch
14:00
Session 3 – Brainstorming: how to improve pharmacovigilance activities
Chair  Sabine Straus, Dutch representative of the PRAC, Medicines Evaluation
Board, The Netherlands
Topic 1: Periodic Safety Update Reports (PSURs) – Writing PSURs, assessments
reports and implementation  Victoria Bodea, Head Pharmacovigilance Europe,
EUQPPV, Ranbaxy
Topic 2: Signal detection for generic medicines  Ilse Sjoholm, Associate Director,
European QPPV, Global Pharmacovigilance, Actavis
Topic 3: Consortia for studies (PASS, DUS…)  Augusto Filipe, Medical Director,
Tecnimede/Farmoz
Topic 4: Inspections  Wendy Huisman, EU QPPV, Teva
15:00
Networking coffee break
15:30
Summary of the brianstorming sessions by the topic leaders and panel discussion
16:25
Closure of the day – wrap up discussion
16:30
Cocktail reception
SEE YOU NEXT YEAR ON 27 JANUARY 2016!
For further information and to register on-line, please visit:
www.egaevents.org/phv.htm or www.egagenerics.com
Lucia Romagnoli - T: +44-7562-876873 - E: [email protected]
Registrations close officially on 12 January 2015 & are subject to availability.
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209