Global Regulatory Perspectives Workshop
Pre-Conference Workshop
Wednesday, May 29, 2019
8:00 – 16:45
The ISCT Global Regulatory Perspectives (GRP) workshop represents the diverse activities and partnerships between international regulatory bodies, industry, clinicians and academia. Take part in this highly interactive program, which includes various hypothetical case studies throughout, and immerse yourself in the global regulatory landscape for CGT clinical translation.
Supporters
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Program Information
Speaker: Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, USA
Confirmed Speakers:
- Ieva Ozolins, PhD, Medical Advisor, Therapeutic Goods Administration (TGA), Australia
- Yoshiaki Maruyama, PhD, Review Director, PMDA, Japan
Confirmed Speakers:
- Steven Oh, PhD, Deputy Director, Office of Tissues and Advanced Therapies, FDA, USA
- Bao-Zhu Yuan, MD, PhD, Department Chief, National Institutes for Food and Drug Control, China
Confirmed Speakers:
- Rachel Witten, MD, Lead Medical Officer, FDA, USA
More information available soon.
To view the full meeting program please refer to Program Schedule.
Organizing Committee
Karen Nichols, Esq. – Co-ChairVP, Regulatory and Quality, Magenta Therapeutics, United States |
Dominic Wall, PhD, FFSc(RCPA) – Co-ChairDirector Pathology, Operations, Peter MacCallum Cancer Centre, Australia |
Shirley Bartido, PhD, Director of Regulatory Affairs, Cellectis, USA |
Christopher Bravery, PhD, Director, Consulting on Advanced Biologicals, United Kingdom |
Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, United States |
Srinivasan Kellathur, PhD, Head, Advanced Therapy Products Unit, Health Sciences Authority, Singapore |
Janet Macpherson, PhD, Product Sales Specialist, Cell & Gene Therapy – Life Sciences, GE, Australia |