Event Details
- Course
-
This event has been completed
Regulatory Affairs for Clinical Trials - April 14, 2014 - April 15, 2014
- Radisson Blu Edwardian Grafton
-
London, United Kingdom
- Introduction
- This 2-day practical course will take delegates through the essential regulatory requirements for clinical research in Europe and wll also include key US requirements which impact on trials in Europe.
The most important areas of regulations and guidelines controlling clinical trials will be covered including: understanding the importance of the EU Clinical Trial Directive; clinical trial authorisations; the increasingly important requirements for running trials in children; requirements for managing investigational medicinal product; legal aspects of clinical trials; pharmacovigilance; data management, GCP requirements; regulatory inspection and more. Topics will also include an update on the latest CT Directive guidelines and other EU Clinical Trial developments.
What Will You Learn?
Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
Develop effective processes for obtaining clinical trials authorisation
Clarify the requirements for running clinical trials in children
Understand the most important legal aspects of clinical trials
- Useful Links
- Reference link 1
- About Organiser
- Pharmaceutical Training International (PTI)
- E: registration@pti-europe.co.uk
-