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

View Course Agenda

Past Participants' Comments

“Very informative and the course material is very thorough.”
David A., Associate II, Elan

“My time was well-spent!.  The course was very informative and timely.  The Course Director was very knowledgeable and well spoken.”
Carlos R., Vaccine QA Compliance, Wyeth

“This was an excellent class covering all aspects of the EU Clinical Trial Directive.  I would recommend this course to anyone who is involved with a clinical study team.”
Theresa B., Principal Clinical Safety Scientist, GSK

"Good introduction/resource to a totally new set of regulations my organization must comply with!  Course Note Book will be a great resource!"
Art A., QA Unit Manager, The Population Council

"I found this course very useful and would be interested in having members of our clinical and regulatory affairs attend this course.  The Course Director was excellent, he kept our interest and was responsive to questions and discussions. Thanks!"
Lisa C., Project Manager, Pfizer

"I enjoyed participating in the training course and consider my time well-spent.  The course material was timely and met my expectations.  The Course Director was knowledgeable and well spoken.  The facilities were very satisfactory and staff of both the hotel and CfPIE were very helpful and cordial.  I would recommend this course to my colleagues and will look forward to other learning opportunities presented by CfPIE."
Maria A., Senior Regulatory Coordinator, Merck

"The course was an excellent foundation on which I can build my experience with the EU Directive!"
Carolyn C., Senior Compliance Specialist, GE Healthcare

"This course was very informative and the information was timely and an important in terms of the regulatory and drug development process ."
Manager, RA, Alexion Pharmaceuticals

"I particularly liked the small class size, personal attention and the extensive knowledge of the presenter."
Manoj J., Clinical Research Manager, Dentsply – Endodontics

"The course was very informative and the content timely, covering all aspects of the EU Clinical Trial Directive.  I will recommend this course to my colleagues."
Ines B., Head of Clinical Pharmacology, Vuk Vrhovac University Clinic

"I have been to courses on similar topics but have to say that this was THE BEST one that I have been to!  Very relevant, with loads of reference tools that I will use again in the future"
Dimitry F., Project Manager, Mitsubishi Pharma Europe

"I enjoyed this course very much.  It was very interactive with small number of participants.  The Course Director was very well informed, always ready to motivate us and was open for discussion.  The course notes will be of great help to me for my future work.  I will surely recommend this course to my colleagues!"
Vesna S., Clinical Trial Site Coordinator, Vuk Vrhovac University Clinic