EnteroBiotix GCP Update

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Course Handout

GCP Update 0621 Handout

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

ICH GCP (R2)

MHRA GCP forum – lots of useful information and examples

MHRA risk assessment examples

MHRA Inspection Metrics 2017-2018

MHRA Inspection Metrics 2018-2019

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

Q&A on Reference Safety Information

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