Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

On 20th of March, The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials.

The guidance was agreed by the Clinical Trials Expert Group (CTEG) of the European Commission, supported by EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of HMA and the GCP Inspectors’ Working Group. It provides a harmonised approach in the conduct of trials, in order to mitigate the negative effects of the pandemic.

https://www.ema.europa.eu/documents/press-release/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic_en.pdf

Need more information ?

BECRO

PLACE MARCEL BROODTHAERS PLEIN, 8 BOX 5
B-1060 BRUSSELS / BELGIUM
PHONE: +32 (0)2 892 40 00
E-MAIL: INFO@BECRO.BE

© 2018 BECRO – ALL RIGHTS RESERVED

Octopix + WordPress = ♥ | Design by Simplexity