This training will provide participants with an understanding of the legislation and guidance covering manufacture and handling of investigational medicinal products in the EU.
The main document we focus on is Annexe 13 of Eudralex Volume 4 which covers requirements for manufacture of medicinal products specifically for use in a clinical trial setting. We also consider key GMP changes coming with the new EU Clinical Trials Regulation and associated guidelines.
We also cover the EU Guideline on IMPs and Non-IMPs – soon to be updated to Auxiliary Medicinal Products.
We also include an interactive workshop session looking at Site Management of IMP: Personnel, Premises and Processes.
Please contact me for more information and to organise your course.