The Ethics Committee of Hannover Medical School is registered with the Federal Institute for Drugs and Medical Devices (BfArM) for the evaluation of research projects with medicinal products in accordance with the Clinical Trial Regulation (CTR).
Advice on research projects with medicinal products in accordance with the CTR will be provided by the so-called "AMG" subcommittee. This is made up of members of the Ethics Committees of the MHH, the University Medical Center Göttingen, the Carl von Ossietzky University Oldenburg and external parties.
Subcommittee AMG according to CTR
Contact details
AMG Subcommittee of the MHH Ethics Committee
- OE 9515 -
Carl-Neuberg-Str. 1
30625 Hannover
With the entry into force of Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use (Clinical Trial Regulation, CTR), the procedure for submitting applications in the EU has changed.
Since January 31, 2023, all applications for new clinical trials in the EU must be submitted via the EMA's Clinical Trial Information System (CTIS).
Under the new legal framework, the local competence of the Ethics Committee for the consultation of clinical trials under the CTR no longer applies. These studies are assigned to an Ethics Committee registered for this procedure in accordance with a nationwide business distribution plan.
The responsible Ethics Committee is not known in advance. The involvement of locally involved Ethics Committees and the function of the former LKP (head of the clinical trial) is omitted.
Regulation (EU) No. 536/2014 (CTR) i. V. m. §§ 40-42 AMG
- The link to Regulation (EU) No. 536/2014 (CTR) can be found here: Regulation - 536/2014 - EN - EUR-Lex
- The link to the German Medicinal Products Act (AMG) can be found here: Medicinal Products Act
Clinical Trial Evaluation Procedure Ordinance (KPBV)
- The link to the Clinical Trial Evaluation Procedure Ordinance (KPBV) can be found here: KPBV
The members of the "AMG" subcommittee of the Ethics Committee of Hannover Medical School are:
Prof. Dr. med. Bernhard Schmidt (Chairman of the "AMG" subcommittee)
Senior Physician, Clinical Department of Nephrology and Hypertension, MHH.
Prof. Dr. Frank Griesinger (Deputy Chairman of the "AMG" subcommittee)
Director, Clinical Department of Haematology and Oncology, Pius-Hospital Oldenburg
Prof. Dr. med. Jürgen Brockmöller (Deputy Chairman of the "AMG" subcommittee)
Director of the Institute of Clinical Pharmacology, UMG
Carola Alvarez Castillo (Deputy Chair of the "AMG" subcommittee)
Legal and Committees Department, UOL
Prof. Dr. med. Arndt Schilling (Deputy Chair of the "AMG" subcommittee)
Head of Research and Development, Clinical Department of Trauma Surgery, Orthopaedics and Plastic Surgery, UMG
Dr. med. Rita Beier
Clinical Department for Pediatric Hematology and Oncology, Pediatric Stem Cell Transplantation, MHH
Prof. Dr. med. Ivan Bogeski
Institute for Cardiovascular Physiology, UMG
Prof. Dr. rer. nat. Edgar Brunner
Institute for Medical Statistics, UMG
Julia Buchinski
Lawyer
Prof. Dr. med. Anibh Das
Clinical Department of Paediatric Kidney, Liver and Metabolic Diseases and Neuropaediatrics, Head of Metabolism, MHH
Prof. Dr. med. Claudia Dellas
Department of Pediatric Cardiology & Intensive Care Medicine, Clinical Department of Pediatrics & Adolescent Medicine, UMG
Prof. Dr. med. Anna-Maria Dittrich
Clinical Department of Paediatric Pneumology, Allergology and Neonatology, MHH
Dr. med. Linda Feldbrügge
Senior Consultant, Clinical Department of General, Visceral and Transplant Surgery, MHH
Dr. med. Justus Graubner
Specialist in general medicine
Dr. med. Jürgen Gronau
Diagnostic and Interventional Radiology, Head of Pediatric Radiology, UMG
Dr. med. Thilo Gronow
Specialist in ophthalmology
Dr. Martin Groß
Medical Director and Head of Neurology Center, MEDIAN Clinical Department, Bad Tennstedt
Sebastian Häckl
Institute of Biometry, MHH
Prof. Dr. rer. medic. Martin Hellmich
Institute for Medical Statistics, UMG
Hendrik Huscher
KIZMO GmbH, Clinical Innovation Center for Medical Technology Oldenburg
Dr. med. Jessica Kaufeld
Clinical Department of Nephrology and Hypertension, MHH
Prof. Dr. med. Armin Koch
Head of the Institute of Biometry, MHH
Ragnild Krüger
Patient representative
Dr. rer. nat. Petra Lachmann
Laywoman
Xiaofei Liu
Institute of Biometry, MHH
Jana Marquardt
Lawyer
Prof. Dr. Bernhard Mühlbauer
Competence Center for Clinical Trials Bremen, Head of the Department of Pharmacology
Dr. jur. Hans, Oehlers
Judge at the OLG Oldenburg, Vice President OLG OL
Prof. Dr. med. Astrid Petersmann
Director of the University Institute for Clinical Chemistry and Laboratory Medicine, Oldenburg Hospital
Dr. des. Ilvie Prince
Institute of History, Ethics and Philosophy of Medicine, MHH
Prof. Dr. Dr. Bernhard Rauch
Director of the Department of Pharmacology and Toxicology, UOL
Josef Roß
Patient representative
Prof. Dr. med. Samir Sarikouch
Head of Clinical Research, Clinical Department of Cardiothoracic, Transplantation and Vascular Surgery, MHH
Dr. med. Christoph Schröder
Deputy Head of Institute, Institute of Clinical Pharmacology, MHH
Prof. Dr. med. Dirk Stichtenoth
Director, Institute of Clinical Pharmacology, MHH
PD Dr. Frank Ursin
Institute of History, Ethics and Philosophy of Medicine, MHH
Dipl.-Ing. Jörg Viering
Head of the Central Research Workshops, MHH
Dr. jur. Caterina Wehage
Specialist lawyer for medical law
Prof. Dr. med. Dipl.-Phys. Thomas Werncke
Institute of Diagnostic and Interventional Radiology
Christoph Wilken
Administrative Unit Data Protection and Information Security Management, UOL
Prof. Dr. med. Jens Wiltfang
Clinical Department of Psychiatry and Psychotherapy, UMG
The rules of procedure of the "AMG" subcommittee of the Ethics Committee can be found here.