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 Biologics 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