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EU Clinical Trial Data Transparency Debate: Where Are We?

Track:
Public Policy/Health Care Compliance/Law

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
365

Room Number:
6E

Level:
Intermediate

Type:
Forum

Title:
EU Clinical Trial Data Transparency Debate: Where Are We?

Chair(s):
Marie Isabel Manley, LLM
Partner, Head of the Regulatory Legal Group
Bristows LLP, United Kingdom

Description:
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(s):
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.

Presentation(s) & Speaker(s):
EU Legal Issues With Respect to the Enhanced Disclosure of Clinical Trial Data
Marie Isabel Manley, LLM
Partner, Head of the Regulatory Legal Group
Bristows LLP, United Kingdom

Current and Future Challenges Facing the Pharmaceutical Industry With Respect to the Enhanced Disclosure of Clinical Trial Data
Hanns-Georg Leimer, PhD
Head of Transparency, Disclosure, and Application Governance within Medical
Boehringer Ingelheim Pharma , Germany

Joint PhRMA-EFPIA Commitments: Compare and Contrast the FDA and EMA Approaches to Clinical Trial Data Transparency
Jeffrey K Francer, JD, MPA
Vice President and Senior Counsel
PhRMA, United States