UCL Institute of Clinical Trials and Methodology



Next Course: Wednesday 6th November 2024

Timings: 10:00 - 15:00

Location: Online via Zoom

Course Facilitators: Jo Burmester

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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.


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


This course is free for UCL members of staff within ICTM Cancer Research UK & UCL Cancer Trials Centre, Comprehensive Clinical Trials Unit at UCL, Medical Research Council Clinical Trials Unit at UCL 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. 

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 UCL staff, Students & Alumni
  • £462 External delegates 

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.