GMP for IMPs for Dermal 2022

Welcome!

Welcome to the course resources page for the GMP Refresher and Update course.

Certificate

If you need a certificate for this course please view the video and then open the lesson at the bottom of this page, watch the video and mark the lesson as completed. You will then be able to download your certificate.

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Handout

Good Manufacturing Practice webinar 2022 ho

Useful Links

Annexe 13 2010

GMP for IMPs Guideline

EMA Guideline on IMPs and Non-IMPs

Auxiliary Medicinal Products Guideline

EU Clinical Trials Regulation

EU GMP Regulation

Eudralex Vol 10 – here you can find all the legislation and guidance for Clinical Trials in the EU. Remember there are two parallel versions currently, one which applies now and one which will apply when the CT Regulation comes in

Eudralex Vol 4

ICH GCP (R2)

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

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

Import of IMP post-Brexit

Responsible person for import

Course Content

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