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GCP courses (CTR/MDR/IVDR) at MHH in 2026
The Center for Clinical Studies (ZKS) at MHH is once again offering continuing education opportunities in the field of clinical studies this year. The courses are aimed at clinical investigators, other medical and non-medical staff, and anyone else who is interested. External participants from public institutions and industry are just as welcome to attend the events as MHH internal participants. Please refer to the table at the bottom of the page for course fees.
This year, in addition to two in-person events, there will also be a live online GCP course.
Basic, advanced, and refresher courses for investigators and medical members of an investigation team for clinical trials, performance studies, or other clinical investigations are conducted in accordance with the current European Regulations (EU) No. 536/2014 (human medicinal products), No. 2017/745 (medical devices), and No. 2017/746 (in vitro diagnostics).
Currently, no specific ICH-GCP E6 R3 update courses are required. The content changes within the updated ICH-GCP mainly affect the sponsor of clinical trials. Content for investigators is included in the above-mentioned basic, advanced, and refresher courses.
Please use the appropriate online form to register:
If you have any questions, please call us at +49 (0) 511/5350-8301 or send an email to direktionsassistenz.zks@mh-hannover.de.
The following courses are offered (held exclusively in German language):
- Thursday, June 11, 2026, 9:00 a.m. – 1:30 p.m. Live online course: CTR/MDR/IVDR refresher. Refresher course for investigators and medical members of an investigation team for clinical trials, performance studies, or other clinical trials in accordance with European Regulations (EU) No. 536/2014 (medicinal products for human use), No. 2017/745 (medical devices) and No. 2017/746 (in vitro diagnostics).
- Tuesday, November 24, 2026, 9:00 a.m. – 4:30 p.m. at the CRC: CTR/MDR/IVDR basic course. Basic course for investigators and medical members of an investigation team for clinical trials, performance studies, or other clinical investigations in accordance with European Regulations (EU) No. 536/2014 (medicinal products for human use), No. 2017/745 (medical devices) and No. 2017/746 (in vitro diagnostics).
- Wednesday, November 25, 2026, 9:00 a.m. – 4:30 p.m. at the CRC: CTR/MDR/IVDR advanced course. Advanced course for investigators, principal investigators, and managers of clinical trials, performance studies, or other clinical investigations in accordance with European Regulations (EU) No. 536/2014 (medicinal products for human use), No. 2017/745 (medical devices), and No. 2017/746 (in vitro diagnostics).
fee per participant
| MHH employees | public institutions | industry | |
|---|---|---|---|
| Advanced and basic courses | 280,00 EUR | 300,00 EUR | 450,00 EUR |
| Refresher course (live online) | 120,00 EUR | 130,00 EUR | 205,00 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.
As an alternative, please attend the basic course.