Clinical Trial Regulatory Requirements 2019

January 24-25, 2019
The Rembrandt Hotel, London

Clinical Trial Regulatory Requirements 2019 will be held in London, United Kingdom on January 24-25, 2019.

Clinical Trial Regulatory Requirements 2019 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 2019 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

Venue (View Map)

The Rembrandt Hotel
11 Thurloe Place,
United Kingdom
  View all Hotels near Venue
View Hotels nearby
1499 Pound Sterling


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

Prices are for evaluation only.

People interested in this event are also interested in:

Managing Vendor/CRO/CMO Oversight 2019
April 8-9, 2019
London, United Kingdom