Regulatory Affairs

Function

The Committee works on the following issues:

• Downsizing Bureaucracy
• Biosafety Risk Management
• National Tissue Engineering Law
• Stem Cell
• Risk Management Plan
• Advanced Cell Therapies
• European centralised authorisation

Members

Co-ordinator:
Prof. Dr. Peter Buckel, SuppreMol GmbH
Markus Hofbauer, Wacker Biotech GmbH

Experts from the following companies:
Markus Ambrosius, Kanzlei Sträter
Dr. Zaklina Buljovcic, Pharmalex GmbH
Dr. Edgar Fenzl, FGK GmbH
Hartmut Fischer, Rittershaus
Dr. Christian Fulda, Jones Day
Dr. Jens Guttmann, Kleiner Rechtsanwälte Partnerschaftsgesellschaft
Dr. med. Christine Günther, Apceth GmbH & Co. KG
Dr. Markus Hofmann, SuppreMol GmbH
Thomas Isensee, Nuvo Research GmbH
Beatrice Jaha, Celgene GmbH
Dr. Alexander Kainz, Fresenius Biotech GmbH
Prof. Dr. Marietta Kaszkin-Bettag, Pharmalex GmbH
Dr. Uwe Kramer, FGK GmbH
Dr. Marion Kronabel, BIO Deutschland e. V.
Dr. Claus Kusnierz-Glaz, PricewaterhouseCoopers AG
Dr. Avril Mankel, NDA Regulatory Service GmbH
Klaudija Milos, DIREVO Industrial Biotechnology GmbH
Dr. Stefan Müllner, Protagen AG
Dr. Alexander Natz, EUCOPE - European Confederation of Pharmaceutical Entrepreneurs AISBL
Stephanie Pichlmeier, Celgene GmbH
Philipp Rastemborski, Osborne Clarke
Dietmar Rescheleit, Amantec GmbH
Prof. Dr. Felicia Rosenthal, CellGenix GmbH
Hildegard Schmatz, NDA Regulatory Service GmbH
Vilma Siodla, co.don AG
Sabine Sperka, Agennix AG
Sascha Tillmanns, SuppreMol GmbH
Dr. Claudia Ulbrich, Ulbrich & Partner Unternehmensberatung