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
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
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
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
Patrick Bedford, Health Canada – Canada
Judith Arcidiacono, FDA – USA
Keith Wonnacott, Novartis – USA

Case Study III


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