European legislation is often far away from daily life, yet in this interactive eLearning course you receive all necessary information in a very practical way. You will get a clear understanding of the current regulatory requirements for Clinical Trials with investigational medicinal products in Europe. The European Clinical Trial Regulation 536/2014 (CTR) is already in place since 2014 and will replace the current EU Clinical Trial Directive 2001/20/EC (EUCTD). However, since the CTR is not effective yet, today, the EUCTD is still in force.
Essentials of the current European Directives 2001/20/EC, 2005/28/EC and the Voluntary Harmonisation Procedure (VHP) are explained. Requirements for submission and approval procedures of clinical trial applications, safety reporting, substantial amendments, and the publication of trial results are explained. You will learn about non-commercial and post-authorisation safety trials. The state-of-the-art regarding implementation and implications will be presented. Much attention of the course goes to the implementation of legislative requirements and guidance documents in practice. In addition, the European Clinical Trial Regulation 536/2014 which will be the future legislative obligatory requirements is outlined. Note however, that in order to have the latest implementation status of the CTR, we recommend you to follow our webinar “The European Clinical Trial Regulation 536/2014 - A Clear Outline“.
Interactive quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment.
All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.
Course timeAt your own pace; the course will remain available online for you for 3 months after you register for it. --------------------- Course Credits: 5 hours
Who should attend
Everyone involved in clinical research including: pharmaceutical companies, Contract Research Organisations (CROs), investigators, site personnel and ethics committee members.
People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry
European directives, regulations and guidance
European legislative documents pertaining to clinical trials with medicinal products
EU Directives 2001/20/EC, 2005/28/EC and the Voluntary Harmonisation Procedure (VHP)
Clinical trial authorisation from ethics committees and authorities
Substantial Amendments and Safety Reporting
Voluntary Harmonisation Procedure
Outline of the Clinical Trial Regulation 536/2014
Up-to-date overview of legislation pertaining to other clinical research topics (medical devices, compassionate use, post-marketing surveillance studies...)
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
Be up-to-date regarding the current rules from the study start to the publication of study results
Know the essentials of current European Clinical Trials Legislation (Directives 2001/20/EC and 2005/28/EC)
Know the procedures to be compliant and reach successful clinical trial submissions
Understand the Voluntary Harmonisation Procedure for centralized clinical trial authorisation
Have an overview of other clinical research legislation (PASS, Exploratory trials compassionate use, PUMA, Medical Devices
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (0)
- Data Management and Informatics (1)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained