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Session 3: Status of the EU Portal and Database
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
A key pillar for implementation of the Regulation is the availability of the EU Portal and Database. EMA have been working to deliver the system and will provide the latest updates alongside the perspective of a user involved in testing. Following the release of the auditable version, the portal and database will be further developed, industry’s perspectives on what needs to be included in the ‘go live’ portal and database will also be discussed.
Speaker(s)
Noemie Manent, PHARMD
TDA-CTT Change Management Lead, European Medicines Agency, Netherlands
Updates from the EMA
Stéphanie Kromar
Senior Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Learning Experience from User Acceptance Tests
Judith Creba, PHD
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU, Novartis Pharma AG, Switzerland
Development Priorities for Post-Audit
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Panel Discussion with Q&A
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