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Virtual

Nov 29, 2021 2:00 PM - Dec 01, 2021 7:00 PM

(Central Europe Standard Time)

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 4: Considerations on Increased Transparency, Data Privacy and Data Sharing

Session Chair(s)

Merete  Joergensen, MBA, MSc

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

Experience and Current Strategy for Exceptional Transparency During the Covid-19 Pandemic

Juan Garcia-Burgos, MD, PhD

European Medicines Agency, Netherlands

Head of Public and Stakeholders Engagement Department

Lora  Killian, MBA

BioNTech/Pfizer Experience On Increased Transparency Demands for Covid-19

Lora Killian, MBA

Pfizer, United States

Clinical Trial Transparency and Disclosure Lead

Christian  Ohmann, PhD

User Perspective for Data Sharing

Christian Ohmann, PhD

Chair of the Independent Data Centre Certification Board of ECRIN ,ECRIN, Germany

Chair of the Network Committee of the European Infrastructure ECRIN-ERIC

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