Public consultation on “Risk proportionate approaches in clinical trials”

The Medicines and Healthcare products Regulator Agency is currently inviting feedback on the EU clinical trials regulations, specifically the document regarding “Risk proportionate approaches in clinical trials”.

The main objective of these recommendations is to provide further information on how a risk proportionate approach can be implemented in clinical trials and also highlights the areas identified in the clinical trials Regulation which support and facilitate such adaptations.

More information is available here.

You can see read the consultation here.

Contributions should be sent by 31 August 2016 by e-mail exclusively to:  SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu

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Published 2. August 2016 in News UK