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SESSION 3: SIGNAL MANAGEMENT (PART I)
Session Chair(s)
Georgy Genov, MD
Head of Pharmacovigilance Office
European Medicines Agency, Netherlands
Menno Van Der Elst, PHARMD, PHD
Head of EU Committees Department
MEB, Netherlands
This session will provide a summary of the key processes related to signal management by marketing authorisation holders introduced by GVP Module IX and the main principles applicable to the signal management pilot. The importance of the signal management activities from a scientific and public health perspective will be addressed by a member of PRAC. The experience in working with the eRMR and the new EVDAS tools will be presented from a marketing authorisation holder perspective.
Speaker(s)
Pilot on signal detection in EudraVigilance by MAHs
Julie Durand
European Medicines Agency, Netherlands
Signal Management Lead, Pharmacovigilance Department
PRAC recommendations on signals
Menno Van Der Elst, PHARMD, PHD
MEB, Netherlands
Head of EU Committees Department
Nils Opitz
Bayer AG, Germany
Head of PV System Management and Analytics
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