戻る Agenda
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)
Updates from the EMA
Noemie Manent, PHARMD
European Medicines Agency, Netherlands
TDA-CTT Change Management Lead
Learning Experience from User Acceptance Tests
Stéphanie Kromar
European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Senior Regulatory Affairs Manager
Development Priorities for Post-Audit
Judith Creba, PHD
Novartis Pharma AG, Switzerland
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU
Panel Discussion with Q&A
Elke Stahl, PHD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department