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TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED?
Session Chair(s)
Ragnar Lofstedt, PhD, MA
Professor of Risk Management
Kings College London, United Kingdom
Over the past ten years there have been a number of regulatory incidents affecting the pharmaceutical sector in both United States and Europe that have led to widespread public and stakeholder distrust of the sector as a whole. As a result, European regulatory agencies have become strong promoters of transparency. The aim of this proposed session (the third annual discussion on the topic) is to shed further light on the transparency agenda in Europe. Issues that will be addressed include: Where are we in terms of the EMA proposal of sharing raw data from clinical trials, how are the public, patient groups and general medical practitioners responding to these changes and new challenges?
Speaker(s)
Panel Discussion
Carmen Bozic, MD, PhD
Biogen, United States
SVP, Portfolio Transformation
Panel Discussion
Andrew D. Jack
Financial Times, United Kingdom
Correspondent
Discussant
Aginus A. W. Kalis, MD
CIBG , Netherlands
Director
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