Open access to clinical trial data?
Opportunities, challenges and risks of sharing clinical trial data on patient level
The Agency is committed to continuously extending its approach to transparency and is planning to make data from clinical trials publicly accessible with January 2014. Format and practice will be defined in the „EMA Policy 0070 on publication and access to clinical-trial data“ (see related links).
This initiative is discussed very controversially within the EU.
Aim of this event is to discuss the different positions in order to enable a more balanced transparency approach.
- Sabine Atzor, Head of EU Regulatory Policies, Roche
- Richard Bergström, Director General, EFPIA (European Federation of Pharmaceutical Industries and Associations)
- Janice Branson, IIS Franchise Head & CSO Primary Care, Novartis
- Thomas Lang, Head of Group Statistics and Methodology, Austrian Agency for Health and Food Safety
- Martin Posch, Head of Medical Statistics, CeMSIIS (Center for Medical Statistics, Informatics, and Intelligent Systems) Med.Univ.Vienna
- Ernst Singer, Chairman of the Ethics Committee, Med.Univ.Vienna
- Michael Wolzt, Head of the Clinical Trials Coordination Center, Med.Univ.Vienna
Main topics for the panel discussion
- EMAs approach to extending transparency
- Data sharing commitments of the pharmaceutical industry
- Expectations of bona-fide researchers
- Implications for the national regulatory systems
Time and place
Medical University of Vienna
Lecture hall 1 (Hörsaalzentrum AKH, level 8) - PLAN
Währinger Gürtel 18-20
Final programme and registration form