Current Program

EU Clinical Trial Regulation 536/2014 (CTR)

Clinical Trial Information System (CTIS)

4. AMG Änderungsgesetz

The target audience of this training are all persons, who want to or have to learn about the CTR and the CTIS. The available possibilities to switch from the “old system” to the “new system” will be explained and pros and cons will be demonstrated. Furthermore, the new authorization and notification processes will be discussed and respective CTIS activities will be shown. Focus is given to the new transparency rules that each sponsor needs to be aware of in order to avoid the publication of personal data or commercially confidential information (too early).

After the seminar, participants will have a good overview of the CTR and the CTIS and will know which roles have to be created within the company to guarantee efficient work procedures internally as well as together with vendors (e.g., CROs). This training day will help you getting started with the EMA training material and with working in CTIS.

Fee: 740 € (19% VAT will be added)

For more information please contact us or register for this course directly via our registration form.