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Synergy in Action

Innovative Technologies Working Group – Adapting Trials (In a Hurry) for Remote Assessment #3

15 May 2020: Adapting Trials (In a Hurry) for Remote Assessment Call 3 – EMA Perspectives

 video

Disclaimers:

EMA experts’ positions that are expressed during this event should be considered personal opinions and should not be taken as the official position of any of EMA’s Committees or Working parties. Official additional guidance can be obtained here: https://www.ema.europa.eu/en/news/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic#

FDA attendee comments should be considered personal opinions and should not be taken as official guidance. Official FDA guidance may be obtained by contacting the Clinicaltrialconduct-COVID19@fda.hhs.gov mailbox.

You may also wish to refer to the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (updated May 11, 2020) to assess whether your questions have been addressed in existing guidance.