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Session 4: Considerations on Increased Transparency, Data Privacy and Data Sharing
Session Chair(s)
Merete Joergensen, MBA, MSC
Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark
During the Covid-19 pandemic focus has been to provide transparency both from the regulatory side and from industry trial sponsors to provide insights into the regulatory decision process, the trial results backing the decisions, and also to provide access to clinical trial data and results. This session will bring forward the viewpoints and challenges from Regulators and Industry perspective, and provide some insight into the needs as seen from the independent researchers side.
Speaker(s)
Juan Garcia-Burgos, MD, PHD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Experience and Current Strategy for Exceptional Transparency During the Covid-19 Pandemic
Lora Killian, MBA
Clinical Trial Transparency and Disclosure Lead, Pfizer, United States
BioNTech/Pfizer Experience On Increased Transparency Demands for Covid-19
Christian Ohmann, PHD
Chair of the Network Committee of the European Infrastructure ECRIN-ERIC, Chair of the Independent Data Centre Certification Board of ECRIN ,ECRIN, Germany
User Perspective for Data Sharing
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