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Session 3 Hot Topics – A Regulator’s Perspective
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV
MSD, Netherlands
Menno Van Der Elst, PharmD, PhD
PRAC member
Medicines Evaluation Board, Netherlands
The activities in the Pharmacovigilance Risk Assessment Committee (PRAC) covers a wide range of procedures, and the level of experience has reached a high level of matureness more than 5 years after the 2012 EU pharmacovigilance legislation came into force. For the QPPV it is important to keep abreast with the PRAC activities, and the current session will provide valuable insight into the functioning of the PRAC. Which are the current hot topics the committee is dealing with? Who are the most important stakeholders and how does the PRAC cooperate with them? Answers to these and many more questions will be provided in this session.
Speaker(s)
An update from the Pharmacovigilance Risk Assessment Committee (PRAC)
Doris Irene Stenver, MD, MPA
Unique Advice, Denmark
Independent Pharmacovigilance Adviser
An update from the Pharmacovigilance Risk Assessment Committee (PRAC)
Menno Van Der Elst, PharmD, PhD
Medicines Evaluation Board, Netherlands
PRAC member
Anja Van Haren, MSc
Medicines Evaluation Board (MEB), Netherlands
Eudravigilance coordinator
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