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.
Essentials of the current European Directives 2001/20/EC, 2005/28/EC and the Voluntary Harmonisation Procedure (VHP) are explained. Current 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. And finally, an overview of updates concerning other legislation of topics related to clinical research.
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.
- Understand how European Legislation works in general
- Be up-to-date regarding legislative 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 a clear understanding on the major, future legislative changes according to the Regulation 536/2014
- 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