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2013 Global Regulatory Perspectives Workshop Presentations

Session I - Regulatory Developments
Regulatory: Kimberly Benton, PhD, Deputy Director
Division of Cellular and Gene Therapies, Food and Drug Administration (FDA), USA
Regulator: Liz Anne Gillham-Eisen, Manager
Blood, Cells, Tissues and Organs/Office of Policy and International Collaboration/Biologics and Genetic Therapies Directorate, Health Canada, Canada
Regulator:Tetsuya Kusakabe, PhD, MPH, Review Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Session II - Clinical Exemptions from Marketing Authorization
Regulator:Paula Salmikangas, PhD, Assistant Professor, Co-ordinating Senior Researcher
Finnish Medicines Agency (FIMEA), Finland

Regulator: Glenn Smith, Director
Therapeutic Goods Administration (TGA), Australia
Industry: Dominic Wall, PhD, Operations Director
Peter MacCallum Cancer Centre, Australia
Industry: Richard Lilischkis, PhD, Clinical Development Director
Regeneus, Australia

Case Study I
Moderator: Janet Macpherson

Session III - Characterization and Comparability: The Role of Reference Standards and Method Standardization
Regulator:Judith Arcidiacono, MSc, International Regulatory Activities Liaison
Food and Drug Administration (FDA), USA
Regulator:Paula Salmikangas, PhD, Assistant Professor, Co-ordinating Senior Researcher
Finnish Medicines Agency (FIMEA), Finland
Industry:Darin Weber, PhD, EVP
Global Regulatory Affairs, Mesoblast, USA
Academic:Michael Kalos, PhD, Director
Translational and Correlative Studies Laboratory, University of Pennsylvania, USA

Case Study II
Moderator: Christopher Bravery

Session IV - Cells from Banked Tissue - Novel Applications, Regulatory Considerations and Questions
Moderator: Karen Nichols, ESQ. RAC, VP
Regulatory and Quality, PerkinElmer, USA

Regulator: Glyn Stacey, PhD, Director
The UK Stem Cell Bank, United Kingdom
Regulatory: Tony Manderson, Principal Evaluator
Cell and Tissue Unit, Biological Science Station, Therapeutic Goods Administration (TGA), Australia
Regulator: Geeta Jotwani, PhD, Assistant Director General (Scientist D)
Indian Council of Medical Research, India
Industry: Aby J. Mathew, PhD, Senior Vice President and Chief Technology Officer
BioLife Solutions, USA

Case Study III
Moderator: Karen Nichols