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Session 1: Clinical Trial Registries and Results Disclosure in the EU and US – An Update
Session Chair(s)
Hanns-Georg Leimer, PhD
Global Head Central Solutions and Services Medicine (CSSM) in Global Biostatisti
Boehringer Ingelheim Pharma GmbH&CO KG, Germany
In 2014, sponsors who conduct trials globally, will have to comply with new requirements for disclosing clinical trial results in Europe in addition to the widely known requirements of ClinicalTrials.gov. At the same time, there is more and more discussion about the target and actual audience of the different registries, and how they relate to each other. This session will provide an update on the requirements and status of ClinicalTrials.gov and the EU Clinical Trials Register, highlighting overlaps and differences
Speaker(s)
EudraCT V9 - Publication of Result-related Information in Europe (via Telecommunications)
Ana Rodriguez Sanchez Beato , PhD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
ClinicalTrials.gov: A General Update
Deborah A. Zarin, DrMed, MD
MRCT Center, United States
Faculty, Harvard Medical Center; Program Director
EudraCT V9 – What to Expect. An Industry Perspective
Merete Joergensen, MBA, MSc
Merete-J Consulting CVR: 34920818, Denmark
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
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