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EU Clinical Trial Data Transparency Debate: Where Are We?
Session Chair(s)
Marie Manley
Partner, Head of EU and UK Life Sciences (UK)
Sidley Austin LLP, United Kingdom
This forum will assess the European legal, political, and policy developments regarding enhanced transparency; the competing arguments for and against enhanced disclosure; and whether increased transparency is in the interests of the European public.
This forum has been developed by the DIA Legal Affairs and Clinical Trial Disclosure Communities.
Learning Objective : Discuss the evolution of the EMA’s policy shift towards enhanced disclosure obligations concerning clinical trial documents; Evaluate the amendments in the proposed Clinical Trials Regulation; Discuss the effects of such disclosures on IP regulatory rights; Assess whether the public interest case for increased data transparency is satisfied.
Speaker(s)
EU Legal Issues With Respect to the Enhanced Disclosure of Clinical Trial Data
Marie Manley
Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
Current and Future Challenges Facing the Pharmaceutical Industry With Respect to the Enhanced Disclosure of Clinical Trial Data
Hanns-Georg Leimer, PhD
Boehringer Ingelheim Pharma GmbH&CO KG, Germany
Global Head Central Solutions and Services Medicine (CSSM) in Global Biostatisti
Joint PhRMA-EFPIA Commitments: Compare and Contrast the FDA and EMA Approaches to Clinical Trial Data Transparency
Jeffrey K. Francer, JD
Eli Lilly and Company, United States
Vice President, Head of Global Regulatory Policy and Strategy
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