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Session 1: Update on New Clinical Disclosure Requirements in the EU and US
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, Denmark
New legislation is coming into force in both US and EU. This session will give the latest updates on the status of the new requirements and their way to implementation seen from EMA and NIH perspective.
Speaker(s)
Future Requirements for ClinicalTrials.gov per the Proposed Rule Making
Deborah A. Zarin, DrMed, MD
MRCT Center, United States
Faculty, Harvard Medical Center; Program Director
Overview of the Clinical Trials Regulation
Noemie Manent, PharmD
European Medicines Agency, Netherlands
TDA-CTT Operations Workstream Lead
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