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Joint Session 1 – Part II: CTR Transparency – Business Considerations
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure, AbbVie, United States
Rose-Marie Swallow
Senior Manager, Policy & Research, Bayer Plc., United Kingdom
The second part of this opening session will concentrate on the transparency aspects of the Clinical Trial Regulation and what this will mean in practice for Sponsors of clinical trials in the future. Following on from the demonstration of the public view of CTIS given in Part 1, this session will examine what this will mean to Sponsors in practice. The session will try to clarify what documentation will be published and when, what data protection considerations Sponsors need to be aware of and what opportunities will be available for Sponsors to use to protect their intellectual property in the future. The panel discussion at the end will afford an opportunity for attendees to raise questions and for further discussion of this topic with representatives of the main stakeholders including, the Commission, EMA, Member States and Sponsors.
Speaker(s)
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
Sponsor Preparedness – Points to Consider
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Panel Discussion, with the participation of:
Pierre-Frederic Omnes, MPHARM
Executive Director, Life Sciences, TransPerfect, France
Contributing Panelist
Laura Pioppo, MSC
ACT EU Programme Manager, European Medicines Agency, Netherlands
Contributing Panelist
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
Contributing Panelist
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
Contributing Panelist
Kristof Bonnarens, MPHARM
Policy Officer Pharmaceuticals, European Commission, Belgium
Contributing Panelist
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