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.
Who is it suitable for?
This course is suitable for anyone involved in manufacture and/or management of Investigational Medicinal Products in clinical trials, for example: Clinical Project Managers, CRAs, CTAs, Clinical Trial Pharmacists, Contract Manufacturers.
To provide delegates with an understanding of:
- Legislation and guidance covering manufacture and handling of investigational medicinal products in the EU
- Recent and forthcoming changes in regulatory requirements
- Practical implications for clinical trials
Delivery of the course will consist of a combination of presentations by the trainer, group discussion and case studies. This course will also be supported by additional resources available from our website.
- Regulatory and Advisory Bodies
Annexe 13 of Eudralex Volume 4
EU Guideline on IMPs and Non-IMPs – soon to be renamed Auxiliary Medicinal Products
New EU Clinical Trials Regulations and Guidelines
- Key GMP changes
Requirements for Manufacturing
- What constitutes manufacturing
- Role of Qualified Person for Manufacturing
- Licenses required
Site Management of IMP
Please contact me for more information and to organise your course.
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