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UCL Institute of Clinical Trials and Methodology

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GMP for IMP

Next Course: Wednesday 3rd July 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.

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 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:

  • £95 Low Middle Income Countries (LMIC)
  • £190 UCL staff, Students & Alumni
  • £230 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.