Update Course VO (EU) 536/2014
Clinical Trials with Medicinal Products
- Interactive eLearning
- approx. 3.5 h
- Mandatory for
Investigators who wish to conduct or manage clinical trials under the new EU Regulation No. 536/2014
- Certificate of Attendance
- The course was accredited with 8 points in category I by the Medical Association (Ärztekammer) of Schleswig-Holstein
Update course on Regulation (EU) 536/2014 ("Clinical Trial Regulation") according to the curriculum of the German Medical Association
Finally - also available as eLearning! Prepare yourself for the new regulations at your own pace – using our self-directed eLearning on your smartphone, tablet, or PC!
Accompany Project Manager Dr.C. Splendt in her considerations on the planning of her two clinical trials and the preparation of the electronic submission via CTIS. Follow Investigator Dr. Ryf in the preparation of a clinical trial according to Regulation (EU) No. 536/2014 - what will be changing, and what needs to be considered? And meet CRA Sabine Kurzler again, who accompanies the investigational team. This eLearning also provides interviews with experts for you!
Our interactive update course can be started, interrupted, and resumed anytime, anywhere. A modular structure and the associated division into chapters with grouped content enable an individual learning experience. From registration on, you will have 4 weeks to complete the course. After successfully finishing the knowledge test, you will receive a certificate of attendance.
Important to know: Our course complies with the requirements of the Federal Medical Association (Bundesärztekammer) for curricular training!
The course was accredited with 8 training points in category I by the Medical Association (Ärztekammer) of Schleswig-Holstein and meets the requirements of the Federal Medical Association for eLearnings.
Whom is this course for? For investigators who wish to conduct or manage clinical trials under the new EU Regulation No. 536/2014 (Clinical Trial Regulation).
What content is conveyed? The modular structure and course content are shown below:
Module 1 - Sponsor Activities
- Chapter 1: The Scope of the CTR
- Chapter 2: Vulnerable Subjects
Module 2 - Application
- Chapter 1: Preparation of the Application
- Chapter 2: Approval of the Submission
Module 3 - On Site
- Chapter 1: On Site
- Chapter 2: Informed Consent
- Chapter 3: Documentation
- Chapter 4: Adverse Events
Module 4 - Formalities
- Chapter 1: Substantial Modifications
- Chapter 2: Reporting Responsibilities
- Chapter 3: Inspections