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The EU Clinical Trial Directive

 
  May 31, 2007  
     
 
The Center for Professional Innovation & Education, Costa Mesa, CA
08/07/07


Who Should Attend

This two-day workshop will be of great value to clinical research professionals and those working with them involved in carrying out clinical trials. It is primarily designed to benefit the following disciplines:

Clinical research and medical operations
Researchers managing combined IMP’s/Medical Devices that also deliver Therapeutics (e.g. medicinal coated stents)
Quality Assurance such as GCP Auditors
Regulatory affairs
Clinical trial supply
Personnel at the study site
CRO personnel
All personnel who need to understand the impact of the EU Clinical Trials Directive


Learning Objectives

Upon completion of this course you will have a thorough knowledge of the EU Clinical Trial Directive requirements. The Directive, which took effect in May 2004, has changed the way firms must deal with Clinical Trial regulations. The content of this course is designed to provide the attendee with the latest information regarding the interpretation and enforcement of these regulations.

Course Description

This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. The course covers all relevant topics associated with the Directive, the reasons behind its introduction and a review of methods for effective implementation.

Key topics to be discussed:

The current regulatory situation in relation to clinical trials in the EU.
The purpose of the new Clinical Trials Directive.
Meeting the New Requirements for Chemical Authorization and Conduct
Understanding the impact the Directive will have on running clinical trials
An overview of key areas of the Directive:
- Regulatory approval/notification
- Ethical review
- Exemptions under the current arrangements
- Informed consent
- Good manufacturing practice
- Safety reporting
- Inspection
Gain a detailed explanation of the key differences between ICH GCP and the new EU Directive

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers: Please contact The Center for Professional Innovation & Education at info@cfpie.com or call +1-610-688-1708 for Speaker information.
 
Deadline for Abstracts: n/a
 
Registration: To Register, please visit www.cfpie.com or call +1-610-688-1708
E-mail: info@cfpie.com
 
   
 
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