Ansprechpartner des BfArM für EU- und ICH-Gremien
Erstellt: 04.03.2006
Aktualisiert: 21.03.2012
Nachstehend finden Sie die Namen der BfArM-Mitarbeiter, die das Institut in den wichtigsten EU-und ICH Gremien im Bereich Arzneimittel vertreten. Für übergeordnete Fragen bezüglich europäischer und internationaler Angelegenheiten steht Ihnen die Stabsstelle P2 „EU, Internationale Angelegenheiten” jederzeit gerne zur Verfügung.
| Organisation/Bereich | Personen |
|---|---|
| Prof. Dr.Walter Schwerdtfeger (member) Dr. Karl Broich (alternate) | |
| Arbeitsgruppen / Working Groups | |
| European Risk Management Strategy (ERMS) | Prof. Dr. Bernhard Sachs |
| Homoeopathic Medicinal Products Working Group (HMPWG) | PD Dr. Werner Knöss (member) Christine Werner (alternate) |
| Clinical Trials Facilitation Group | Dr. Elke Stahl |
| HMA Task Force on Availibility of Resources at NCAs for MRP/DCP | Dr. Peter Bachmann |
| European Medicines Agencies Cooperation on Legal and Legislative Issues (EMACOLEX) | Henning Völkel |
| HMA/EMA Office of Training Steering Group (OTSG | n.n. |
| Working Group of Enforcement Officers (WGEO) | Dr. Marcus Wittstock |
| GMPD Inspectors Subgroup | Gabriele Schwarz |
| Working Group on Quality Management | Brigitte Mauel-Walbröl (chair) |
| Telematic Support Group (TSG) | Dino Soumpasis |
| Benchmarking Steering Group | Brigitte Mauel-Walbröl |
| Organisation/Bereich | Personen |
|---|---|
| Dr. Peter Bachmann (member) Gabriele Eibenstein (expert) | |
| Arbeitsgruppen / Working Groups | |
| EMA/CMDh Sub-Group on Paediatric Regulation | Gabriele Eibenstein |
| CMDh-v Sub-Group on Variation Regulation | Susanne Winterscheid (chair) |
| Joint CMDh/PhVWP Working Group | Dr. Peter Bachmann Prof. Dr. Bernhard Sachs |
| Working Party on the Future of the CMDh | Gabriele Eibenstein |
| eCTD Interlinking Group | Dr. Peter Bachmann (für NtA und CMDh) |
| CTS Working Group | Dino Soumpasis (chair) |
| Organisation/Bereich | Personen |
|---|---|
| Wissenschaftliche Ausschüsse / Committees | |
| Committee for Medicinal Products for Human Use, CHMP | PD Dr. Harald Enzmann (member) Dr. Martina Weise (alternate) |
| Herbal Medicinal Products Committee, HMPC | PD Dr. Werner Knöss (chair) Dr. Birgit Merz (alternate) |
| Committee for Orphan Medicinal Products, COMP | Dr. Rembert Elbers |
| Paediatric Committee, PDCO | Dr. Birka Lehmann |
| Arbeitsgruppen / Working Parties | |
| Scientific Advice Working Party, SAWP | Dr. Elmer Schabel (member) Dr. Norbert Benda (alternate) |
| Joint CHMP/CVMP Quality Working Party, QWP | Dr. Cornelia Nopitsch-Mai |
| Biologics Working Party, BWP | Dr. Brigitte Brake |
| Safety Working Party, SWP | Frau Dr. Susanne Brendler-Schwaab Dr. Peter Kasper (expert genotoxicology) |
| Pharmcovigilance Working Party | Prof. Dr. Bernhard Sachs |
| GCP Inspectors Working Group und Inspectors Subgroup | Gabriele Schwarz |
| Invented Names Review Group, NRG | Dino Soumpasis |
| Quality Review of Documents Group, QRD | Rita Offermann |
| EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) | Gabriele Eibenstein (für CMDh) |
| Working Party on Community Monographs and Community Lists, MLWP | PD Dr. Werner Knöss (vice chair) Dr. Jacqueline Wiesner (member) |
| Zeitlich befristete Arbeitsgruppen / Temporary Working Parties | |
| Similar Biological Medicinal Products Working Party | Dr. Martina Weise (vice chair) PD Dr. Hans-Karl Heim |
| Cardiovascular Working Party | Dr. Martina Weise (additional expert) |
| Central Nervous System Working Party | Dr. Karl Broich (vice chair) |
| Infectious Diseases Working Party | PD Dr. Norbert Schitzler Dr. Sybille Fuchs (observer) |
| Oncology Working Party | Dr. Ulrike Hermes |
| Pharmacokinetics Working Party | Dr. Henrike Potthast |
| Rheumatology / Immunology Working Party | Dr. Susanne Reiter |
| Biostatistics Working Party | Dr. Norbert Benda |
| Gastroenterology Draftig Group | Dr. Elmer Schabel |
| Radiopharmaceuticals Drafting Group | Dr. Johannes Pohly |
| IT-Arbeitsgruppen / IT Working Groups | |
| Telematic Management Committee (TMC) | "Dr. Karlheinz Zinnhobler (als Co-chair der Eudravigilance TIG) Dino Soumpasis (als Chair der CTS-Users Group)" |
| EUTCT (EU Telematic Controlled Terms) | Thomas Balzer |
| Telematic Implementation Groups (TIGs) | |
| Eudranet | Dr. Hubertus Franzen (member) Stefan Riegel (Vertreter) |
| Eudrapharm | Thomas Balzer |
| Eudravigilance | Dr.Karlheinz Zinnhobler (co-chair) |
| Eudravigilance Steering Committee | Dr. Norbert Paeschke |
| EudraCT | Dr. Andrea Marzoll Ralf Gerwers (Vertreter) |
| EudraCT Joint Operation Group (JOG) | Dr. Andrea Marzoll Ralf Gerwers (Vertreter) |
| Electronic Submissions (=Telematics Implementation Group for electronic submission and ICH Implementation (TIGes) ) | Dr. Klaus Menges |
| Product Information Management, PIM Steering committee | Dr. Klaus Menges |
| Product Information Management, NCA Business Team | Dr. Klaus Menges (chair) Dino Soumpasis (member) |
| European Review System, EURS | Dr. Klaus Menges |
| Organisation/Bereich | Personen |
|---|---|
| Quality/Biotech | Dr. Brigitte Brake |
| Safety | Dr. Peter Kasper |
| Organisation/Bereich | Personen |
|---|---|
| NtA (Notice to Applicants Group) | Dr. Peter Bachmann |
| Drug Precursors Committee | Annette Rohr |
| Arbeitsgruppen | |
| Medical Devices Experts Group (MDEG) | Dr. Ekkehard Stößlein |
MDEG Vigilance Group | Dr. Ekkehard Stößlein |
MDEG Working Grouß on Clinical Investigation and Evaluation (CIE WG) | Dr. Thomas Fischer |
MDEG Expert Working Group TSE | Dr. Gisela Ininger |
MDEG In-vitro Diagnostics Directive - Annex II Working Group | Dr. Rüdiger Siekmeier |
MDEG Borderline and classification | Dr. Ekkehard Stößlein |
| Temporäre Gremien / Temporary Groups | |
| New & Emerging Technologies in Medical Devices | Dr. Bruno Heinz |
| Ad hoc Group on the development of implementing guidelines for Directive 2001/20/EC | PD Dr. Thomas Sudhop |