The EU Clinical Trial Directive™

Course Description

This course focuses on understanding and implementing the requirements of the EU Clinical Trial Directive. The course covers all relevant topics associated with the Directive, and a review of methods for effective implementation. The course consists of lecture and interactive exercises to re-enforce the learning.

Key topics to be discussed:

• The current regulatory situation in relation to clinical trials in the European Union
• The purpose of the new Clinical Trial Directive
• Implementing the EU clinical trial requirements
• The impact the Directive will have on running clinical trials
• The key differences between the EU Clinical Trials Directive, FDA Regulations and ICH Guidelines

Who Should Attend

This two-day training course will be of value to clinical research professionals conducting clinical studies in the European Union either as stand alone trials or as part of a multi-national clinical study program.

The course is designed to benefit the following disciplines:

• Clinical operations staff conducting trials with drugs, biologics or combination products
• Quality Assurance (GCP Auditors)
• Regulatory Affairs
• Clinical trial supply
• All personnel who need to understand the impact of the EU Clinical Trial Directive (e.g. project management, study site staff, CRO personnel, etc.)

Learning Objective

Upon completion of this course you will have a working knowledge of the EU Clinical Trial Directive requirements.

This course is designed to provide attendees with:

• The latest information regarding the interpretation and enforcement of these regulations
• An understanding of how to implement and be compliant with the Directive
• An understanding of how the EU Clinical Trial Directive differs from the US FDA Regulations and ICH Guidelines

Past Participants' Comments

"I really enjoyed the class. The EU CTD was very easy to Understand I've taken a course in the past for EU CTD and this was the best! I would recommend to colleagues." Kim A., Pharmacovigilance Manager, Shire

"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, Glaxo (GSK)

"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 fantastic 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

"The instructor did a great job in covering a lot of material in such a short time. I look forward to other learning opportunities with this Course Director." Michael D., Underwriting Director, CNA Insurance

"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

"The Course Director has a wealth of knowledge which surpasses any resource that I have come in contact with thus far. I really enjoyed the course!" Rochelle K., Contract Analyst, Centocor, Inc.

"Excellent class…the best I have been to in years. I walked away with a wealth of information that I will use everyday!" Linda D., Director, Gemin X Inc.

"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, Pfizer

"The instructor provided me with documentation which I will use daily. He presented in such a pleasant, knowledgeable manner that I look forward to taking another CfPIE course in the future. I will definitely recommend him to my colleagues." Robyn T., Manager, Global Regulatory Affairs, J&J

"Thank you for the course. I appreciate the well-organized and very thorough binder reference information that was provided to participants. The instructor was very knowledgeable in the EU Clinical Trial Directive information." Geri P., Sr. Documentation Specialist, MedaRex

"The course reference material is invaluable. I will have to keep it under lock and key when I get it to the office!" Jenny C., Clinical Research Manager, EMACA