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CLINICAL TRIAL REGISTRIES
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
The EU Clinical Trials Register has been available since March 2011. Publication of result-related information in Europe will start with the availability of EudraCT Version 9, which is scheduled for October, 2013. For compliant, efficient, and consistent registration and results information across registries, it is essential that protocols, analyses, result synopses, and reports of clinical studies are “disclosure ready” and integrated in the publication plan. In addition, study results will be made available via the EU Clinical Trials Register prior to approval, which is a paradigm change for stakeholders.
Speaker(s)
EudraCT V9 – Publication of result-related information in Europe, Regulatory perspective
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
Writing Study Protocols and Reports “Disclosure Ready”
Doug Rush, PhD
Xogene Services, United States
Disclosure Specialist, Cliinical Trials Transparency
EudraCT V9 – What to expect, an industry perspective
Neil Newman
Eli Lilly, United Kingdom
Business Consultant - Regulatory And Patient Safety EU & Emerging Markets
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