World News: 12:50 GMT Friday 7th December 2018. [Research and Markets via Globe Newswire via SPi World News]
Dublin, Dec. 07, 2018 (GLOBE NEWSWIRE) -- The conference has been added to offering.
Attending this course will help ensure you are familiar with the regulatory requirements for running clinical trials and with these recent developments. The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for pharmaceutical, biotechnology companies and study sites.
Understand the current framework of clinical trial regulations in Europe
Overview and review of key areas of the EU Clinical Trial Directive
Brief overview of the GCP Directive
The new EU Clinical Trial Regulation and how this will replace the EU Clinical Trials Directive
Clinical trial regulatory authorisation and amendments
Clinical Trial Application (CTA) and how this will change with the new Clinical Trial Regulation
Ethics Committee (EC) submissions and approval
Running clinical trials in children: the paediatric plan and ethical considerations
Brief overview of legal aspects of clinical trials
Investigational medicinal product
Pharmacovigilance and adverse event reporting
Brief overview of other recent EU and FDA developments in clinical trial requirements including:
Brief considerations for preparing for regulatory inspection
Summary and close
For more information about this conference visit
Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Clinical Trials, Medical Law
Globe Newswire: 12:50 GMT Friday 7th December 2018
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