EU Clinical Trials legislation and guidance

The legislation governing clinical trials in the EU is changing.  This course covers a refresher on the current applicable legislation, the Clinical Trials and GCP Directives, and also the new Clinical Trials Regulation which will apply in the next couple of years.  We look at the key requirements and the practicalities of running clinical trials in the EU and the changes coming in with the new Regulation.

We also discuss the current status and implications of Brexit.


The new Regulation covering clinical trials in the EU will bring about some major changes in the approval and conduct of clinical trials in EU Member States.  This module provides a detailed introduction to the requirements of this legislation and also highlights the key differences from previous legislation.

Who is this module for?

Everyone involved in conducting clinical research in the European Union, for example Medical Directors, Clinical Operations staff, Clinical Project Managers, CRAs, CTAs, Investigators, Research Nurses, Study Site Co-ordinators.

At the end of this module you should know

  • The background to the introduction of this legislation
  • The main requirements of this legislation
  • The main differences from previous legislation

Course Content:

Background to the Clinical Trials Regulation

  • The European Union And European Legislation
  • Development Of The New EU Regulation (536/2014)

Refresher on Current Legislation

  • Clinical Trials Directive
  • GCP Directive

New Clinical Trials Regulation

Part 1: General Concepts And Considerations

Part 2: Articles Of The EU Regulation

  • Chapter One – General Provisions
  • Chapter Two – Authorisation Procedures
  • Chapter Three – Authorisation Procedure For A Substantial Modification Of A Clinical Trial
  • Chapter Four – Application Dossier
  • Chapter Five – Protection Of Subjects And Informed Consent
  • Chapter Six – Start, End, Temporary Halt, And Early Termination Of A Clinical Trial
  • Chapter Seven – Safety Reporting In The Context Of A Clinical Trial
  • Chapter Eight – Conduct Of A Clinical Trial, Supervision By The Sponsor, Training And Experience, Auxiliary Medicinal Products
  • Chapter Nine – Manufacturing And Import Of Investigational Medicinal Products And Auxiliary Medicinal Products
  • Chapter Ten – Labelling
  • Chapter Eleven – Sponsor And Investigator
  • Chapter Twelve – Damage Compensation
  • Chapter Thirteen – Supervision By Member States, Union Inspections And Controls
  • Chapter Fourteen – IT Infrastructure
  • Chapter Fifteen – Cooperation Between Member States
  • Chapter Sixteen – Fees
  • Chapter Seventeen – Implementing Acts And Delegated Acts
  • Chapter Eighteen – Miscellaneous Provisions
  • Chapter Nineteen – Final Provisions

Annexes I-VII


  • Current Status
  • Likely implications

Please contact me for more information and to organise your course.

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