PSI Webinar: Surrogacy
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Date: Wednesday 3rd July 2024
Time: 10:00-15:00 BST
Location: Online
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.
Objectives:
To provide delegates with an understanding of:
For more information and to register, please visit: https://www.ucl.ac.uk/clinical-trials-and-methodology/study/short-courses/gmp-imp
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
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