Back to Agendas
Session 2 Hot Topics
Session Chair(s)
Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and International QPPV
Abbvie, United Kingdom
Since implementation of the new legislation the Pharmacovigilance Committees of the industry trade associations have been raising topics for discussion with EMA and Member States where there are areas of uncertainty and clarification is required. Typically it is the larger pharmaceutical companies who are members of these trade associations and for companies who are not members it is difficult to know what are the areas of interest under discussion. This session will share the key topics of interest and progress made to date.
Speaker(s)
Post-Authorisation Safety Studies/Post-Authorisation Efficacy Studies/Off label use
Emma Du Four, MBA
-, United Kingdom
Regulatory and R&D Policy Professional
Patient Support Programmes
Sue Rees, MS
Sue Rees Consultancy Ltd, United Kingdom
Director
Risk Management Definitions and Approaches
Maria Grazia Zurlo, MD
Pfizer, Italy
Worldwide Safety and Regulatory
Periodic Safety Update Reports
Jean Kilgour-Christie, BSN, MSc
Novartis Pharma AG, Germany
Deputy EU-QPPV
Risk Management Plans for Generics, Problems, Proposals and Progress
John Barber
Dr. Reddy's Laboratories (UK) Ltd., United Kingdom
QPPV and Director, Head of Pharmacovigilance, European Operations
Have an account?