GMP for IMPs Live Webinar

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This webinar 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.

Who is it suitable for?

This webinar 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
  • Recent and forthcoming changes in regulatory requirements
  • Practical implications for clinical trials

Example Content:

Background

  • Documents
  • Regulatory and Advisory Bodies
  • Definitions

Annexe 13 of Eudralex Volume 4

  • Content
  • Implications

EU Guideline on IMPs and Non-IMPs – soon to be renamed Auxiliary Medicinal Products

  • Content
  • Implications

New EU Clinical Trials Regulations and Guidelines

  • Key GMP changes

Requirements for Manufacturing

  • What constitutes manufacturing
  • Role of Qualified Person for Manufacturing
  • Licenses required

Site Management of IMP

  • Personnel
  • Premises
  • Equipment

 

 

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