News: This eLearning course has been verified for any new legislation update needed in March 2018 and is up-to-date.
You need a clear and hands-on overview and be up-to-date of the most current national regulatory legislation for Clinical Trials with investigational medicinal products but also medical devices in Germany?
We cover the majority of countries and courses are developed in a consistent way, to offer a similar learning experience. Visit our catalogue regularly, as we are expanding it on a monthly basis.
You can book this course only or book a bundle and pay less: 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 German regulations, and you can learn at your own pace.
It is 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 News & 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 who needs to have a good overview of the Local Regulatory Requirements.
- Everyone who needs to comply local regulatory training requirements prior to performing clinical research submission 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
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
- Get an overview of the local clinical trial legislation in, for both medicinal products and medical devices
- Be able to identify legally required documents
- Know the procedures to be compliant and reach successful clinical trials submissions.
Important: this course is mentioning EC recommendations regarding MPG (Medical Device Act) but can not be considered as a complete training on medical device regulations. In case of question, contact info [at] eccrt.com