戻る Agendas
MANAGING THE RISK OR MANAGING THE PLAN?
Session Chair(s)
Maarten Lagendijk, MSC
Deputy EU QPPV
MSD, Netherlands
Are Risks Written in Stone? Strategies to Successfully Remove Risks from Risk Management Plans
Learning Objective : 1 Techniques to adequately characterise risks for discusisons with regulatory bodies 2 How to use pharamcovigilance activities to support the characterisation 3 How to build up a structured rational to propose risk removal
Speaker(s)
RMPs for Generics
Kora H Doorduyn-van der Stoep, MSC, RPH
MEB, Netherlands
EU Representative
RMPs for Mature Products
Wendy Booth
GlaxoSmithKline, United Kingdom
Director, Global Clinical Safety & Pharmacovigilance
Are Risks Written in Stone? Strategies to Successfully Remove Risks from Risk Management Plans
Samuel Ramsden, MSC
Boehringer Ingelheim International Gmbh, Germany
Head of Risk Management Office