2nd Annual EUCRAF Workshop in Freiburg, Germany

What currently matters for Biopharmaceuticals in Europe

Chairman: Prof. Johannes Löwer, President IABS, Former President BfArM and PEI

Session 1 - The changing regulatory environment

• Agencies news and typical practical issues of the last year. Gopalan Narayanan, MHRA
• The new Pharmacovigilance legislation. Monika Pietrek, Pietrek Associates
• Biosimilar monoclonal antibodies. Christian Schneider, Danish Medicines Agency
• Agency experience with Type II variations in manufacture. Steffen Gross, Paul-Ehrlich-Institut (PEI)
• Virus Safety. Johannes Löwer, IABS
• EU and U.S. practice for new formulations and dosage forms. Lois Hinman, Novartis
• Clinical trials in the EU. Ilona Reischl, AGES – Austrian Agency for Health and Food Safety
• Academic research undergoing ATMP regulation. Edward Geissler, University Hospital Regensburg
• Biopharmaceuticals in other regions
  • Japan. Tetsuya Tanimoto, PMDA
  • China. Martina Schwinger, Novartis

Session 2  - The science and strategy of development of biopharmaceuticals

• Personalised medicine. Anja Langeneckert, F. Hoffman-La Roche
• Update on the ICH S6 guideline revision process. Jennifer Sims, Novartis
• Regulatory pathways and HTA. Jan Müller-Berghaus, Paul-Ehrlich-Institut (PEI)

Take advantage of

• Panel discussions and
• Manifold networking opportunities

Please find further information on the agenda, booking forms, travel and accommodation here: http://www.eucraf.eu/news-and-press/newsticker/workshop-02-03-february-2012.html

Contact:
Programme manager: Anita Dioszegi
Phone: +49 761 13774424
Email: anita.dioszegi@eucraf.eu

Study Director: Dr. Gabriele Schäffner-Dallmann
Email: Gabriele.dallmann@eurcaf.eu

EUCRAF - the European Centre for Regulatory Affairs Freiburg offers in collaboration with the University of Strasbourg the postgraduate Diploma „Regulatory Affairs for Biopharmaceuticals” developed by distinguished experts from authorities, universities and companies. EUCRAF is also a platform for Regulatory Affairs experts to facilitate the exchange on current matters related to biopharmaceuticals.

15% discount on registration fee for BIO Deutschland members – mention “BioDeutschland member” on the registration form.