Clinical Trial Regulatory Requirements

Description

Clinical Trial Regulatory Requirements is a conference dedicated to key regulatory & guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulations.

Clinical Trial Regulatory Requirements covers topics such as:

  • Key areas of the EU Clinical Trial Directive
  • Current framework of clinical trial regulations in Europe
  • The new EU Clinical Trial Regulation and how this will replace the EU Clinical Trials Directive
  • Brief overview of the GCP Directive
  • Clinical Trial Application (CTA) and how this will change with the new Clinical Trial Regulation
  • Clinical trial regulatory authorisation and amendments
  • Running clinical trials in children: the paediatric plan and ethical considerations
  • Ethics Committee (EC) submissions and approval
  • Investigational medicinal product
  • Brief overview of legal aspects of clinical trials
  • Brief overview of other recent EU and FDA developments in clinical trial requirements including:
  • Pharmacovigilance and adverse event reporting
  • Brief considerations for preparing for regulatory inspection

Future Events

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Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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