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Session 1: The New EudraVigilance system and implications for Signal Management in the EU network
Session Chair(s)
Georgy Genov, MD
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
European Medicines Agency, Netherlands
Rodrigo Postigo
Scientific Administrator
European Medicines Agency, Netherlands
This session will provide an overview of the impact in the EU Signal Management procedure following the go-live of the new EudraVigilance system and the full implementation of the EudraVigilance access policy (revision 3) in November 2017. The different aspects for implementation of the updated Good Pharmacovigilance Practice Module IX and the submission of validated signals to regulatory authorities will be developed. The role of the PRAC and the expectations following the monitoring of the EudraVigilance data by Marketing Authorisation Holders will be also discussed.
Speaker(s)
Go-live of the new EudraVigilance system: What will happen in November 2017
Sabine Brosch, PharmD, PhD, MPharm
European Medicines Agency, Netherlands
Data Protection Officer
GVP IX Module on Signal Management: Highlights of Revision 1 and practical implementation
Julie Durand
European Medicines Agency, Netherlands
Signal Management Lead, Pharmacovigilance Department
PRAC expectations on the Signal Management procedure following the go-live of the new EudraVigilance system
Sabine Straus, MD, PhD, MSc
Medicines Evaluation Board (MEB), Netherlands
PRAC Chair, Staff Member
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