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.
Co-ordinator
Dr. Edgar Fenzl
FGK Clinical Research GmbH
Experts from the following companies
- AiCuris Anti-infective Cures AG Apogenix AG
- Aquisgranainvest GmbH
- AvenCell Europe GmbH
- Berlin Partner für Wirtschaft und Technologie GmbH
- BioKryo GmbH
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Boergen Rechtsanwaltskanzlei
- CMS Hasche Sigle Partnerschaft von Rechtsanwälten und Steuerberatern mbB
- ConsulTech GmbH
- Covington & Burling LLP
- CTI Clinical Trial and Consulting Services Europe GmbH
- CureVac SE
- D+B Rechtsanwälte Partnerschaft mbH
- Dentons Europe LLP
- Elschner Consulting
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs AISBL
- FGK Clinical Research GmbH
- Fidelio Partners GmbH & Co. KG
- Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
- Heidelberg Pharma AG
- Immunic AG
- ITM Medical Isotopes GmbH
- Jones Day
- Medigene AG
- Miltenyi Biotec B.V. & Co. KG
- Minaris Regenerative Medicine GmbH
- MorphoSys AG
- NDA Regulatory Service GmbH
- Neuwerk Rechtsanwälte
- Nordmark Pharma GmbH
- Osborne Clarke
- Pfizer Pharma GmbH
- Pinsent Masons
- PricewaterhouseCoopers GmbH WPG
- ProBioGen AG
- Roche Diagnostics GmbH
- Sacura GmbH
- Sanofi-Aventis Deutschland GmbH
- Sartorius CellGenix GmbH
- SIRION Biotech GmbH
- TETEC AG
- TME Pharma AG
- TRIGA-S e. K.
- Vertex Pharmaceuticals (Germany) GmbH
- Wacker Biotech GmbH