Ofra Axelrod
Deputy Director, The Institute for Standardization and Control of Pharmaceuticals, Israeli MOH

FDA is it really a black hole?
Joyce Frey
Managing Member, Frey-Vasconcells Consulting, LLC
Former Deputy Director, Office of Cellular, Tissue, and Gene Therapies (OCTGT) with the Center for Biologic
s Evaluation and Research (CBER) FDA

The Regulatory Challenges for the Approval of Advanced Therapies in Europe
Margarida Menezes Ferreira
National Scientific Advice Coordinator Senior Assessor/Medicines Evaluation Department
INFARMED - National Authority of Medicines and Health Products, I.P. Portugal
Member of the Committee for Advanced Therapies and of the Biologics Working Party/CHMP – EMA
A Harmonized Approach in Regulation of PLX-PAD
Racheli Ofir
Pluristem, MATAM Park, Haifa, Israel
