On Demand Webcast: EMA regulatory process for clinical trials
Trainer: Laura Brown
On demand webcast, based on live virtual meeting: 18 December 2019
Webcast release date: 04 February 2020
Webcast expiration date: 31 December 2020
Duration: 1 hour
CME accreditation: UEMS-EACCME® 1.0 CME

Content

1. Setting up a clinical trial

  • European Union (EU) Clinical Trials Directive and EU Clinical Trials Regulation
  • What do you need to do to set up a clinical trial?
  • Budget planning
  • Principles of the International Council for Harmonization Good Clinical Practice (ICH GCP)
  • Key new areas of ICH GCP addendum (R2)
  • Investigator responsibilities
  • Sponsor responsibilities
  • Obtaining permission to start a clinical trial
    • EU Clinical Trials Directive and EU Clinical Trials Regulation for authorization
    • Ethical approval:
      • What is involved?
      • Tips for EC submissions
  • Clinical study to public databases: EU Clinical Trials register, Clinicaltrials.gov

2. Ongoing activities for a clinical trial

  • Informed consenting
  • Ensuring quality and data integrity
  • Trial documentation
  • Pharmacovigilance: adverse event (AE) reporting, suspected serious unexpected adverse reactions (SUSARs)

3. End-of-trial activities

  • End-of-study documentation
  • Audit and Inspection
  • Archiving

Learning objectives
After completing this module, participants should be able to:

  • Explain the European Union (EU) clinical trial regulatory process
  • List the regulatory activities for setting up, running, and closing a clinical trial
  • Describe how to set up a clinical trial to comply with the EU regulatory requirements

 

The webcast "EMA regulatory process for clinical trials", made available on https://ologyeducation.org/acquire/ and organized by Ology Medical Education, is accredited by the European Accreditation Council for Continuing Medical Education (EACCME) to provide the following CME activity for medical specialists. Each medical specialist should claim only those credits that he/she actually spent in the educational activity. The EACCME is an institution of the European Union of Medical Specialists (UEMS). Only those e-learning materials that are displayed on the UEMS-EACCME website have formally been accredited. Through an agreement between the European Union of Medical Specialists (UEMS) and the American Medical Association (AMA), physicians may convert EACCME credits to an equivalent number of AMA PRA Category 1 CreditsTM. Information on the process to convert EACCME credit to AMA credit can be found at https://www.ama-assn.org/education/earn-credit-participation-international-activities.

On Demand Webcasts

This training programme is made possible by a contribution from Novartis Pharma AG. Novartis does not have any influence on the content and all items are subject to independent peer and editorial review.

This programme is organized by Ology, a global provider of independent medical education that develops CME initiatives for the international medical and scientific community. Ology is an Adelphi in Healthcare Communications company. For further information about other Adelphi companies please see the Adelphi Group website.

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