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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, 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)
Celine Bourguignon, PHARMD, MPHARM, MS
Senior Director Regulatory Policy & Intelligence, GSK, Belgium
Update on Clinical Module in EudaMed (Medical Device Regulation)
Carine Cochereau
Vice President International Regulatoy Affairs, Integra Life Science, Belgium
Experience with implementing Clinical Trial Disclosure Requirements of the ISO 14155/2020
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