Regulatory Affairs
Function
The Working Group on Regulatory Matters aims to promote research on and development of innovative medicinal products by removing unnecessary bureaucracy and current obstacles in the regulatory parameters. Among other topics, it deals with the conditions for clinical trials, the legal framework for medicinal products for innovative therapies, and the national, European and international legal provisions for trialling and licensing biopharmaceutical products. In addition, the working group aims to improve collaboration between companies, hospitals and doctors in research on and development of innovative medicines.
Members
Co-ordinator
| Dr. Edgar Fenzl | FGK Clinical Research GmbH |
Experts from the following companies
| Dr. Kathrin Adlkofer | Cellbox Solutions GmbH |
| Julia Akdemir | MorphoSys AG |
| Dr. Jürgen Bednarz | TETEC AG |
| Barbara Behle | Miltenyi Biotec GmbH |
| Dr. Dirk Bernhardt | DiBe-Consulting |
| Manuel Bilke | Apceth Biopharma GmbH |
| Dr. Xenia Boergen | bbCell GmbH |
| Dr. Jan Castonguay | CellGenix GmbH |
| Monika Eck-Schaupp | NDA Regulatory Service GmbH |
| Steffi Elschner | Elschner Consulting |
| Dr. Edgar Fenzl | FGK Clinical Research GmbH |
| Anna Fitze | Osborne Clarke |
| Dr. Christian Fulda | Jones Day |
| Dr. Marco Grebe | Co.don AG |
| Dr. Christine Günther | Apceth GmbH & Co. KG |
| Dr. Andrea Hauser | RCI Regensburger Centrum für Interventionelle Immunologie |
| Jana Hase | GEMoaB Monoclonals GmbH |
| Stefan Kinner | Vertex Pharmaceuticals (Germany) GmbH |
| Dr. Christian Kaps | Co.don AG |
| Dr. Susann Kleinsimon | Berlin Partner für Wirtschaft und Technologie GmbH |
| Dr. Andrea Kotz | Bayerische Patentallianz GmbH |
| Dr. Uwe Kramer | FGK Clinical Research GmbH |
| Dr. Claus Kusnierz-Glaz | PricewaterhouseCoopers AG WPG |
| Dr. Maike Melullis | Nordmark Arzneimittel GmbH & Co. KG |
| Vilma Methner | bbCell GmbH |
| Dr. Thomas Müller | BioKryo GmbH |
| Dr. Alexander Natz | EUCOPE - European Confederation of Pharmaceutical Entrepreneurs AISBL |
| Dr. Udo Nirenberg | CellGenix GmbH |
| Michael Pehl | GEMoaB Monoclonals GmbH |
| Dr. Matthias Peukert | NEUWERK Rechtsanwälte |
| Dr. Jasmin Podufall | Berlin Partner für Wirtschaft und Technologie GmbH |
| Dr. Liane Preußner | Miltenyi Biotec GmbH |
| Dietmar Rescheleit | Sacura GmbH |
| Dr. Marco Riedel | ProBioGen AG |
| Silvia Riffel-Friedrich | AiCuris Anti-infective Cures GmbH |
| Prof. Dr. Felicia Rosenthal | CellGenix GmbH |
| Dr. Birgitta Sauer-Stoschek | Medigene AG |
| Dr. Isabel Schemainda | NDA Regulatory Service GmbH |
| Dagmar Schwertner-Knoll | BioGenes GmbH |
| Andrea Stöckle | Boehringer Ingelheim Pharma GmbH & Co. KG |
| Dr. Silke Thomsen | CBR Biotech Strategies GmbH |
| Dr. Maren von Fritschen | EUCOPE - European Confederation of Pharmaceutical Entrepreneurs AISBL |
| Dr. Hartmut Voss | Dievini Hopp BioTech holding GmbH & Co. KG |
| Piet Weinreich | Osborne Clarke |
| Dr. Harry Wild | Thermo Fisher Scienctific GmbH |
| Alexa Winter | Pfizer Pharma GmbH |
| Dr. Jörn Witt | CMS Hasche Sigle Partnerschaft von Rechtsanwälten und Steuerberatern mbB |
| Prof. Dr. Stephan Wnendt | MLM Medical Labs GmbH |
| André Zöller | Vertex Pharmaceuticals (Germany) GmbH |