You need a clear and hands-on understanding and be up-to-date of the most current national regulatory legislation for Clinical Trials with investigational medicinal products but also medical devices within one or multiple specific European Countries?
We cover the majority of countries, our courses are developed in a consistent way, to offer a similar learning experience. Visit this section of our website regularly, as we are expanding our catalogue on a monthly basis.
Make your choice within our catalogue at the end of this page: the more Local Clinical Trial Legislation courses you take the less you pay per course!
This eLearning course will fulfil your expectations in a very practical way. It is an interactive approach to review and comprehend local regulations, and you can learn at your own pace.
It is designed and regularly updated by local subject matter experts to always reflect the latest status of local legislations, both for medicinal products and medical devices.
Interactive quizzes for self-assessment are included to provide a better understanding 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 wil remain available online for you for 3 months after you register for it.--------------------- Course Credits: 1,5 hours
Who should attend
- Everyone involved in clinical research, including: Pharmaceutical companies, Contract Research Organisations (CROs), Investigators, Site Personnel.
- People from clinical operations, regulatory affairs, quality assurance and pharmacovigilance departments involved in monitoring activities (on-site or medical monitoring) of investigational sites.
- Everyone who wants to acquire knowledge of the Local Regulatory Requirements.
- Everyone who needs to comply local regulatory training requirements prior to performing work locally.
- Legal Framework governing clinical trials with investigational medicinal products and medical devices
- Process, timelines and fees for achieving clinical trial authorisation from the competent authorities (Ethics Committee and National Competent Authorities)
- Amendments & End of Trial Notification
- Safety Reporting
- Get an overview of the local clinical trial legislation in, for both medicinal products and medical devices
- Be able to identify and create legally required documents
- Know the procedures to be compliant and reach successful clinical trials submissions.
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (1)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (0)
- Data Management and Informatics (0)
- 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