Industries: Pharma / BiotechMedical Device

Understanding & Implementing the New EU Clinical Trial Regulation

Course Director: Michael A. Pierro

Course Description - Course runs 9:00 to 5:00 both days

This course focuses on understanding and implementing the requirements of the new EU Clinical Trial Regulation and how it differs from the previous EU Directive and other country’s requirements. The Course covers all relevant topics associated with the Regulation, the reasons behind its replacement of 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 Clinical Trial Regulation & why it replaces the Directive
  • Implementing the EU Clinical Trial requirements 
  • Understanding the impact the Regulation will have on running clinical trials
  • A detailed explanation of the key differences between the EU Clinical Trials Regulation and FDA Regulations and ICH Guidelines
  • The key differences between the EU Regulation and the requirements in China, India and Japan

Who Should Attend

This two-day training course will describe the new Regulation while focusing on implementation of its requirements. This course will be of value to clinical research professionals conducting clinical trials in the European Union either as stand alone or as part of a multi-national clinical study program.  GCP and GMP requirements for the EU will be compared to those of the US.  The course will also make comparison to China, India and Japan.

The course is designed to benefit the following disciplines:

  • Clinical Operations conducting trials with drugs, biologics or Medical Devices delivering medications (e.g. medicinal coated stents)
  • Quality Assurance(GCP Auditors)
  • Regulatory affairs
  • Clinical trial supply
  • All personnel who need to understand the impact of the EU Clinical Trial Regulation (e.g. project management, study site staff, CRO personnel, etc.)

Course Agenda

First Day

Background Information

  • Clinical Trials pre-Directive
  • Directive Development Timeline
  • Overview of the clinical trial initiation process in the US

Describing The EU CT Directive

  • Definition
  • Purpose
  • Scope
  • Member states
  • EU Regulatory organization & roles
  • 2001/20EC 23 Articles: Requirements
  • 2005/28/EC GCP Requirements
  • 2003/94/EC GMP Requirements

Clinical Trial Differences Between the EU & US

  • Major differences between US & EU requirements

Clinical Trial Application and Registration Process

  • Sponsor
  • EudraCT application process
  • CTA application contents
  • CTA submission/revision Process
  • CTA fee structure
  • End of trial declaration

Second Day

Ethics Committee Submission & Review Process

  • Definition & role
  • Responsibilities
  • Sponsor submission/re-submission process
  • Composition, functions, operations & procedures
  • Documentation reviewed
  • Approval process

Implementing the Directive

  • GCP requirements

GMP

  • GMP requirements

Safety Reporting Requirements

  • Eudravigilence database
  • SUSAR reporting requirements
  • Reporting non-SUSARs
  • Post marketing reporting requirements

Recent Initiatives & Future of the Directive

  • Risk Based Monitoring
  • Implementing Direct Data Entry
  • Performance of Pharmacovigilance
  • The Future of the Directive
    • 2010 Survey
    • Industry Feedback
    • Potential Changes

Course Review / Q & A

Learning Objective

Upon completion of this course you will have a working knowledge of the EU Clinical Trial Regulation requirements in the EU and how they differ with the US and Asian region requirements.

This course is designed to provide attendees with understanding of:

  • The regulatory requirements for conducting clinical trials in the European Union
  • How to implement the Regulation and remain compliant
  • How the EU Clinical Trial Regulation differs from the US FDA Regulations and ICH Guidelines

Testimonials

"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

Frequently Asked Questions

Does this course discuss the differences between 21 FFR and the EU Directive?

Yes, The focus of this course is the European Clinical Trials Directive. However, this course discusses the similarities and differences between the Directive and the US Code of Federal Regulations.

Are the proposed changes to the Directive discussed?

Yes, the proposed changes to the current Directive are discussed. The rationale for these changes is also discussed.