Pharma / BiotechMedical Device
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:
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:
Describing The EU CT Directive
Clinical Trial Differences Between the EU & US
Clinical Trial Application and Registration Process
Ethics Committee Submission & Review Process
Implementing the Directive
Safety Reporting Requirements
Recent Initiatives & Future of the Directive
Course Review / Q & A
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:
"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
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.
Yes, the proposed changes to the current Directive are discussed. The rationale for these changes is also discussed.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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