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DISCLOSURE OF CLINICAL TRIAL DATA - WHAT DOES THE FUTURE HOLD?

Track:
The Role of Transparency and Ethics: Legal aspects

Day & Time:
March 26, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
1302

Room Number:
F2

Level:
Advanced

Type:
Session

Title:
DISCLOSURE OF CLINICAL TRIAL DATA - WHAT DOES THE FUTURE HOLD?

Chair(s):
Peter W.L. Bogaert, MA
Partner
Covington & Burling LLP, Belgium

Description:
This session will review the legal principles that govern the release of clinical trial data to third parties, such as researchers but also the public in general. The principles governing reactive and proactive will be discussed, as well as the latest status of the litigation before the EU courts and the new Clinical Trials Regulation and its potential impact on transparency.

Learning Objective(s):
Understand the legal principles that apply to the proposed EMA initiative to proactively publish clinical trial data. Understand the various balances to be made under the legal principles.

Presentation(s) & Speaker(s):
A View from a National Regulator on the Legal Debate Concerning Access to Clinical Trial Data
Diederick Slijkerman
Medicines Evaluation Board, Netherlands

Industry View on the Legal Aspects of Access to Clinical Trial Data
Victoria Kitcatt, LLM
Vice President and Assistant General Counsel, European Regulatory Law
Pfizer Limited, United Kingdom

Update on the Legal Situation and Pending Cases before the EU Court
Peter W.L. Bogaert, MA
Partner
Covington & Burling LLP, Belgium