2-Day Course: Clinical Trial Regulatory Requirements (London, United Kingdom - July 8-9, 2019)

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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


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Related Topics: Clinical Trials, Medical Law

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Globe Newswire: 12:50 GMT Friday 7th December 2018

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