The EU Clinical Trial Directive

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.

Areas Covered in the seminar:

• 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.

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.

Who will benefit:

This 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

Instructor Profile:

Robert J. Russell, For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

Follow us :