2015 GRP Workshop Presentations
New Around the Globe
Presenter: Scott Burger, Advanced Cell & Gene Therapy – USA

Session I
Global Regulatory Update
Moderator: Karen Nichols, Conkwest Inc. – USA
Speakers:
Yi-Chu Lin, Taiwan FDA – Taiwan
Laila Mouawad, Brazilian Health Surveillance Agency, ANVISA – Brazil
Akihiro Shimosaka, Research Foundation for Community Medicine – Japan
Darin Weber, Mesoblast – USA

Session II
Building the Regulatory Strategy
Moderator: Janet MacPherson, Royal Prince Alfred Hospital – Australia
Speakers:
Kimberly Benton, FDA – USA
Björn Carlsson, Medical Products Agency (MPA) – Sweden
Jacques Galipeau, Emory University – USA

Case Study I

Session III
Clinical Trials - Academic to Commercial Translation of Clinical Products
Moderator: Dominic Wall, Peter MacCallum Cancer Centre – Australia
Speakers:
Patrick Bedford, Health Canada – Canada
Kurt Gunter, Cell Medica Inc – USA
Christopher Bravery, Consulting on Advanced Biologicals – United Kingdom

Case Study II

Session IV
International Regulatory Convergence
Moderator: Aisha Khan, University of Miami – USA
Speakers:
Patrick Bedford, Health Canada – Canada
Judith Arcidiacono, FDA – USA
Keith Wonnacott, Novartis – USA

Case Study III

 

© 2015 International Society for Cellular Therapy. All rights reserved.
ISCT, International Society for Cellular Therapy, and the ISCT logo are registered service marks of The International Society for Cellular Therapy.
The BEACON and lighthouse logo is a service mark of The International Society for Cellular Therapy.