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
Dr. Hartmut Fischer RITTERSHAUS Rechtsanwälte Partnerschaftsgesellschaft
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
Dr. Christian Kaps Co.don AG
Dr. Andrea Kotz Bayerische Patentallianz GmbH
Dr. Uwe Kramer FGK Clinical Research GmbH
Dr. Claus Kusnierz-Glaz PricewaterhouseCoopers AG WPG
Vilma Methner bbCell GmbH
Dr. Thomas Müller BioKryo GmbH
Dr. Alexander Natz EUCOPE - European Confederation of Pharmaceutical Entrepreneurs AISBL
Dr. Udo Nirenberg CellGenix 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