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Session 4: EudraVigilance data for safety monitoring of medicinal products
Session Chair(s)
Georgy Genov, MD
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
European Medicines Agency, Netherlands
Sabine Straus, MD, PhD, MSc
PRAC Chair, Staff Member
Medicines Evaluation Board (MEB), Netherlands
This session will provide with the perspective and experience of a National Competent Authority with the monitoring of the EudraVigilance data and the role of Lead Member State for the signal management procedure in the EU. The session will also explore the opportunities the EudraVigilance provides together with the optimal use of the data for an effective functioning of the EU regulatory network. The future challenges approaches and research in light of the SMART - Work Stream Methods – Roadmap will be also presented.
Speaker(s)
Use of EudraVigilance data by National Competent Authorities: The role of the Lead Member States in the EU Signal Management process
Martin Huber, MPH, MPharm
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
Opportunities with the release of EudraVigilance data: Optimal use of the data for signal management and training support
Rodrigo Postigo
European Medicines Agency, Netherlands
Scientific Administrator
SMART - Work Stream Methods: Roadmap and new perspectives in signal detection
Gianmario Candore
European Medicines Agency, Netherlands
Data Scientist
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