GMP for Clinical Trial Material (CTM)

Review of recent changes

Clinical Trials Material


Course description

In this 3,5 hour session online, you will get information about GMP requirements currently applicable to your manufacturing of material for clinical trials and ow it varies depending on which phase you are in (I, II or III). It highlights the potential changes that will follow when current Annex 13 to EU GMP will be superseded by the Detailed Commission guidelines and the Regulation 546/2014. It has now been confirmed that det date of entry into application of the Regulation is January 22nd 2022. It also summarises similarities and differences compared to US FDA requirement.

Course outline

  • Risk based approach to GMP for Clinical Trial Material
  • Reasons for EU regulatory changes and how it impacts GMP
  • Walk-through of requirements and how they increase depending on Phase
  • Comparison with US FDA requirements and interpretations

Learning objectives

After this session you will be aware of the potential changes that you may have to implement in your QMS/GMP procedures for Clinical Trial Material. You will also be aware of current interpretation of the requirements and specific FDA aspects.

Who should attend

Personnel within Pharmaceutical companies who are responsible for Quality, either with the sponsor or with the manufacturing entity. Auditors, Quality Assurance, GMP compliance and regulatory affairs professionals should also attend to gain the necessary information and knowledge.


Preferably basic understanding of GMP requirements and at least 1 year experience of pharmaceutical industry and supply of clinical trial material.




Anna Lundén