Date: Tuesday November 17, 2009 afternoon session
Time: 13h30 till 17h00 Welcome coffee as from 13h on
Language: English
Location: De Montil, Essene (Affligem)

Speakers:

Prof. Paul Declerck, Department of Pharmaceutical Sciences, KU Leuven
Mr Patrick Celis, Scientific Administrator, EMEA, Head of the CAT Secretariat
Mrs Karen De Smet, Non-Clinical Assessor FAGG, member of the BMWP and alternate member in the SWP and VWP
Mr Wilfried Dalemans, Vice President Regulatory Affairs and Corporate Quality, TiGenix

Agenda

1. Scientific Introduction to Biotechnology and Advanced Therapies
Prof. De Clerck

2. Biologicals, Biotechnological Products and Advanced Therapies: Legal and Regulatory Frame work
Mr Patrick Celis

Coffee Break

3. Advanced Therapies: Point of View of the Industry
Mr Wilfried Dalemans

4. Biosimilars
Mrs Karen De Smet

5. Questions and Answers Session