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
| Julia Akdemir | MorphoSys AG |
| Dr. Jürgen Bednarz | TETEC AG |
| Barbara Behle | Miltenyi Biotec GmbH |
| Dr. Dirk Bernhardt | DiBe-Consulting |
| Dr. Diana Beyer | NOXXON Pharma AG |
| Manuel Bilke | Minaris Regenerative Medicine GmbH |
| Dr. Xenia Boergen | bbCell GmbH |
| Patricia Chimot-Marolle | CellGenix GmbH |
| Monika Eck-Schaupp | NDA Regulatory Service GmbH |
| Steffi Elschner | Elschner Consulting |
| Dr. Edgar Fenzl | FGK Clinical Research GmbH |
| Dr. Christian Fulda | Jones Day |
| Dr. Gabriele Gaßmann | Apogenix AG |
| Dr. Jens Hain | TRIGA-S |
| Jana Hase | GEMoaB Monoclonals GmbH |
| Markus Hofbauer | Wacker Biotech GmbH |
| Peter Homberg | Dentons Europe LLP |
| Dr. Michael Jandke | Miltenyi Biomedicine GmbH |
| Stefan Kinner | Vertex Pharmaceuticals (Germany) GmbH |
| Dr. Andrea Kotz | Bayerische Patentallianz GmbH |
| Dr. Uwe Kramer | FGK Clinical Research GmbH |
| Dr. Claus Kusnierz-Glaz | PricewaterhouseCoopers AG WPG |
| Dr. Klaus Maleck | TETEC AG |
| Dr. Maike Melullis | Nordmark Arzneimittel GmbH & Co. KG |
| Vilma Methner | bbCell GmbH |
| Dr. Thomas Müller | BioKryo GmbH |
| Dr. Darius-Jean Namdjou | Immunic Therapeutics |
| 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 |
| 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 |
| Dr. Daniel Schubart | ConsulTech GmbH |
| Marit Stirnberg | Miltenyi Biotec B.V. & Co. KG |
| 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 |
| Antje Wallstab | Vertex Pharmaceuticals (Germany) GmbH |
| Dr. Martin Wendland | NDA Regulatory Service GmbH |
| Prof. Dr. Heike Andrea Wieland | Sanofi-Aventis Deutschland GmbH |
| Alexa Winter | Pfizer Pharma GmbH |
| Dr. Roland Wiring | CMS Hasche Sigle Partnerschaft von Rechtsanwälten und Steuerberatern mbB |
| Dr. Jörn Witt | CMS Hasche Sigle Partnerschaft von Rechtsanwälten und Steuerberatern mbB |
| Prof. Dr. Stephan Wnendt | Aquisgranainvest GmbH |
| CTI Clinical Trial and Consulting Services Europe GmbH | Matthias Wuepping |
| Dr. Guido Zibell | Pfizer Pharma GmbH |
| André Zöller | Vertex Pharmaceuticals (Germany) GmbH |