Next Course: Wednesday 6th November 2024
Timings: 10:00 - 15:00
Location: Online via Zoom
Course Facilitators: Jo Burmester
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.
Intended audience
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:
- Legislation and guidance covering manufacture and handling of investigational medicinal products in the EU/UK
- Recent and forthcoming changes in regulatory requirements
- Practical implications for clinical trials
Fees
This course is free for Ïã¸ÛÁùºÏ²Ê members of staff within ICTM Cancer Research UK & Ïã¸ÛÁùºÏ²Ê Cancer Trials Centre, Comprehensive Clinical Trials Unit at Ïã¸ÛÁùºÏ²Ê, Medical Research Council Clinical Trials Unit at Ïã¸ÛÁùºÏ²Ê and PRIMENT Clinical Trials Unit) although places are limited. Please contact ictm.cpd@ucl.ac.uk for a validation code to make the registration payment.Â
Attendees from outside of the ICTM will be required to pay an attendance fee. Fees are based on the attendee's organisation as follows:
- £193 Low Middle Income Countries (LMIC)
- £385 Ïã¸ÛÁùºÏ²Ê staff, Students & Alumni
- £462 External delegatesÂ
Delegates from LMIC Countries
The Institute is also able to offer 2 free places to delegates that meet the following criteria on a first come first basis:
- Residents in Low Middle Income Countries (LMIC) working with CTU Trial Teams
Please ask CTU project lead to email course administrator requesting exemption, (ictm.cpd@ucl.ac.uk)
If you have any questions about the course, please email ictm.cpd@ucl.ac.uk.