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TRANSPARENCY – IS CLEARING THE PAST CLOUDING THE FUTURE?

Track:
The Role of Transparency and Ethics: Legal aspects

Day & Time:
March 26, 9:00AM - 10:30AM (Central European Standard Time)

Session Number:
1301

Room Number:
F2

Type:
Session

Title:
TRANSPARENCY – IS CLEARING THE PAST CLOUDING THE FUTURE?

Chair(s):
Christopher J. Foreman, JD, LLM
Director, Legal Affairs, Mid-Europe II Region
Merck Sharp & Dohme Inc., Belgium

Description:
This session will set the scene for the Theme’s topic of Transparency. Why must data be disclosed by regulators and are the current disclosure obligations suited for that objective?

Presentation(s) & Speaker(s):
The Transparency Imperative: A boon for drug development and for public health
Guido Rasi, MD
Executive Director
European Medicines Agency, European Union, United Kingdom

Transparency on the Level of Clinical Trials Data - the perspective of a National Competent Authority
Thomas Lang, MSc
Biostatistician
AGES-MEA, Austria

Do the Current Proposals by Regulators Meet the Objective of Transparency? An Industry Perspective
Richard Bergstroem, MS
Director-General
EFPIA, Belgium