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UCL Institute of Clinical Trials and Methodology

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GMP for IMP

Date of next course: 5th July 2023

Times: 10am-4pm

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 staff from Units within ICTM (CRUK-CTC, CCTU, MRC CTU at UCL and PRIMENT) although places are limited. Places on this course are limited, If demand exceeds the number of places, places will be awarded to those who the course presenters believe will benefit most from the course.Fees are based on the attendee's organisation as follows:

  • £85 for attendees from other UCL departments;
  • £85 for student attendees
  • £65 for attendees from Low Middle Income Countries (LMIC)
  • £200 for attendees from other not-for-profit organisations
  • £275 for attendees from for-profit organisations.

    The Institute is also able to offer 2 free places to delegates that meet the following criteria on a first come first basis:

  • Resident in Low Middle Income Country (LMIC)
  • Working with CTU Trial Teams

Please ask CTU project lead to email course administrator requesting exemption, (ictm.cpd@ucl.ac.uk)

The ICTM CPD Administrator will advise successful applicants of the location and fee payment process.


If you have any questions about the course, please email ictm.cpd@ucl.ac.uk