The Center for Clinical Studies (ZKS) at the MHH is once again offering training opportunities within the framework of clinical studies this year. The courses are aimed at clinical investigators, as well as other medical and non-medical staff and all interested people. External participants from public institutions and industry are just as welcome at the events as internal MHH participants. We are currently conducting a survey to identify whether there is a demand for “online live GCP courses”. If you are interested, please fill out the questionnaire (only in German). Please see the table at the bottom of the page for the course fees.

The courses take place exclusively as face-to-face events. We are looking forward to a vivid exchange.

On July 11, 2025, the German Medical Association published the new investigator curricula, following their approval by the Working Group of Ethics Committees (AK-EK) in June.

This requires a redesign of the content of the basic, advanced, and refresher courses for investigators and physician members of an investigation team for clinical trials, performance studies, or other clinical trials under European Regulations (EU) No. 536/2014 (human medicinal products), No. 2017/745 (medicinal devices), and No. 2017/746 (in vitro diagnostic medical devices).

No specific ICH-GCP E6 R3 update courses are currently required. The content changes within the updated ICH-GCP primarily affect the sponsor of clinical trials. Content for investigators is included in the aforementioned basic, advanced, and refresher courses. According to the transition period of one year, the old courses/qualifications will remain valid.

To register, please use the appropriate online form:

• for ZKS employees
• for other MHH employees
• for external participants

If you have any questions, please call 0511/5350-8301 or email direktionsassistenz.zks@mh-hannover.de.

We offer the following courses (held exclusively in German):

1. Monday, 2025-24-11, 9:00 a.m. – 4:30 p.m. at the CRC: AMG/MPDG basic course – according to new curricula! Basic course for investigators and medical members of a review team of clinical trials, performance studies, or other clinical trials under European Regulations (EU) No. 536/2014 (human medicine), No. 2017/745 (medical devices), and No. 2017/746 (in vitro diagnostic medical devices).
2. Tuesday, 2025-25-11, 9:00 a.m. – 4:30 p.m. at the CRC: Advanced Course on the Medical Devices Act (MPDG) (according to the old curricula, still valid during the transition phase). Advanced Course on Clinical Trials under European Regulation (EU) No. 745/2017 (medical devices).
3. Wednesday, 2025-26-11, 9:00 a.m. – 4:30 p.m. at the CRC: Advanced Course on the German Medicines Act (AMG) (according to the old curricula, still valid during the transition phase). Advanced Course on Clinical Trials according to European Regulation (EU) No. 536/2014 (human medicine)