Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

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Session 5: Disclosure Requirements in Medical Device Studies

Session Chair(s)

Matthias Zerm, PhD

Lead Expert, Clinical Trial Disclosure and R&D Processes

Merz Therapeutics GmbH, Germany

This session will provide an update on the clinical trial disclosure requirements under EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) and on the progress of the clinical module in EUDAMED which is scheduled to become available in Q4 2022. We will also look at how the clinical trial disclosure requirements in ISO 14155:2020 are implemented in practice.

Speaker(s)

Update on Clinical Module in EudaMed (Medical Device Regulation)

Celine Bourguignon, PharmD, MPharm, MS

GSK, Belgium

Senior Director Regulatory Policy & Intelligence

Experience with implementing Clinical Trial Disclosure Requirements of the ISO 14155/2020

Carine Cochereau

Integra Life Science, Belgium

Vice President International Regulatoy Affairs

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