[July 07, 2014]

Research and Markets: Clinical Trial Regulatory & Guideline Requirements Seminar: Update on the New Clinical Trial Regulation - 2nd-3rd October 2014, London UK

Research and Markets (http://www.researchandmarkets.com/research/lx3flt/clinical_trial) has announced the addition of the "Clinical Trial Regulatory & Guideline Requirements - Including an Update on the New Clinical Trial Regulation" conference to their offering.

2 & 3 October 2014 - The Rembrandt Hotel, London

The EU Clinical Trials Regulation was finalized and published in the Official Journal of the EU in May 2014 and is due to come into force in 2016. This new Regulation will replace the European Clinical Trials Directive (2001/20/EC). This course will provide an essential understanding to help with compliance for clinical trials, particularly carried out in the EU.

This course will take you through th regulatory and guideline requirements for clinical research in Europe, including the new Clinical Trial Regulation and existing Directive requirements. The key US requirements which impact on trials being carried out in Europe will also be covered.

Attending this course will help ensure you are familiar with the regulations for running clinical trials and with these recent requirements. 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 both Biopharmaceutical companies and study sites. Regulatory inspectors expect those involved in clinical trials to be aware of the regulations for controlling clinical trials - this essential course will also be ideal for this.

Agenda

• Understand the Framework of Clinical Trial Regulations in Europe
• The New EU Clinical Trial Regulation
• The GCP Directive
• Clinical Trials Authorisation: Regulatory Approval and Ethical Approval
• Ethics Committee (EC) Submissions and Approval
• Clinical Trial Regulatory Authorisation and Amendments
• Running Clinical Trials in Children
• Brief Overview of Legal Aspects of Clinical Trials
• Pharmacovigilance and Adverse Event Reporting
• Brief awareness of Clinical Trial Data Management including EDC and e-Source (News - Alert)
• Brief Overview of Other Recent EU Developments in Clinical Trial Requirements
• Brief Awareness of FDA Recent Developments
• Regulatory Inspection

For more information visit http://www.researchandmarkets.com/research/lx3flt/clinical_trial

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