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Virtual

29 nov 2021 2:00 p.m. - 01 dic 2021 7:00 p.m.

(Central Europe Standard Time)

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 1: Strategic Aspects of Disclosure and Transparency Beyond Compliance

Session Chair(s)

Thomas  Schindler, PHD

Thomas Schindler, PHD

Director Global Regulatory Affairs - Regulatory Operations

BioNTech SE, Germany

The session will look at role of transparency beyond the need for compliance with regulations. Topics will be the benefits of transparency for regulators and pharmaceutical companies in building understanding and trust. Only trusted partners will be able to engage with society to foster medical and pharmaceutical innovation. Another aspect is the (potential) impact of transparency efforts on patients who are looking for understandable information on diseases, clinical trials data, and new medicines.

Speaker(s)

Juan  Garcia-Burgos, MD, PHD

Transparency as a key element to gain public trust on regulatory activities

Juan Garcia-Burgos, MD, PHD

European Medicines Agency, Netherlands

Head of Public and Stakeholders Engagement Department

Zsofia  Bakonyi, MA

Beyond Regulation - Catering for the digitally enabled patient who is looking for information

Zsofia Bakonyi, MA

EFPIA, Belgium

Senior Manager Partnerships

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