ESSENTIAL GUIDE TO
CLINICAL TRIAL
REGULATIONS

Conference Date: 30-31 Oct 2008
Conference Ref: A10-4108
Fee: £1199 + VAT
Venue: The Rembrandt Hotel, London

This course will take you through the regulatory requirements for clinical research in Europe as well as including key US requirements which impact on EU  trials

To ensure clinical trials meet the requirements of the regulatory authorities it is essential that your trials are run to the latest regulatory requirements. Attending this course will help ensure you are up to date with all recent regulatory developments.

The course will highlight the most important of these key changes and how these are likely to impact on trials now and in the future for both Pharmaceutical companies and the Study Sites. 

 Key topics to be covered include:-

• The importance of the EU Clinical Trial Directive
• Clinical Trial Authorisations
• The new requirements for Paediatric Trials
• Requirements for managing Investigational Medicinal Products
• Legal Aspects of Clinical Trials
• Complexities of Pharmacovigilance
• Data Management
• GCP Requirements
• Regulatory Inspection