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Face-To-Face GCP courses (AMG/MPDG) at MHH in November 2025
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:
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):
- 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).
- 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).
- 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)
fee per participant
| MHH employees | public institutions | industry | |
|---|---|---|---|
| Advanced and basic courses | 280,00 EUR | 300,00 EUR | 450,00 EUR |
FAQs
In principle, validity is unlimited. However, ethics committees require
- a refresher course of at least 4 teaching units (TU) focusing on new legal or ethical standards, if you have not been actively involved in clinical research for three calendar years.
- an update course of at least 2 teaching units (TU) If significant legal changes have been made (e.g., relevant European or national amendments) and you are actively involved in clinical research.
Note: Some international sponsors also require refresher training every three years.
Currently, the AKEK does not require any specific ICH-GCP E6 (R3) update courses. The content changes in the updated ICH-GCP E6 primarily affect sponsors of clinical trials. The above-mentioned basic, advanced, and refresher courses include content for investigators.
The transition phase will last until June 30, 2026. Until then, "old" courses may still be offered and attended. After that date, only courses based on the new curriculum will be available. Nevertheless, if possible, we recommend attending courses based on the current curriculum from now on.
Case 1: You have been actively involved in clinical research since completing the basic course.
The time gap is irrelevant, and you are eligible to attend an advanced course. You have gained the desired practical experience and skills since taking the basic course.
Case 2: You have not been active since the basic course, or you have taken a long break from clinical research.
If there has been a significant gap and significant legal changes have occurred, it is advisable to take a refresher course. However, if you have kept up with legal changes, you can attend an advanced course.
If you have a significant knowledge gap and have not learned about current European legislation in the basic course, we recommend taking a refresher course. However, if you have kept up with legal changes, you can attend an advanced course, which covers refresher material as well. The advanced course includes content such as ICH-E6 (R3) for investigators.
Ethics committees only recognize live, in-person courses or virtual, in-person courses in a blended learning format (i.e., a combination of self-study and in-person training). Courses consumed statically in a virtual format (e.g., via video recording) are not recognized. Please attend one of our in-person courses and take our survey to determine which online live courses, if any, are relevant for you.
As an alternative, please attend the basic course.