GCP Update Webinar April 2019

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Useful Links

EU Clinical Trials Regulation

Eudralex Vol 10– here you can find all the legislation and guidance for Clinical Trials in the EU

HRA Guidance on GDPR


MHRA GCP forum– lots of useful information and examples

MHRA GCP Inspection Metrics 2016-2017

MHRA Guidance on responding to Inspection findings

MHRA Infringement Notice: Freelance monitor

MHRA Infringement notice: Investigator

MHRA Serious Breaches Guidance

UK SI 2004 1031– Medicines for Human Use (Clinical Trials) Regulations

UK SI 2006 1928– Medicines for Human Use (Clinical Trials) Amendment Regulations

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