Global Regulatory Perspectives Workshop
Pre-Conference Workshop
Wednesday, May 29, 2019
8:00 – 16:45
Room: 218
Karen Nichols, Esq., VP, Regulatory and Quality, Magenta Therapeutics, United States
Dominic Wall, PhD, FFSc(RCPA), Director Pathology, Operations, Peter MacCallum Cancer Centre, Australia
Speaker: Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, USA
Moderator:
- Rebecca Lim, PhD, Associate Professor, Obstetrics & Gynaecology, Monash University, Australia
Confirmed Speakers:
- Ieva Ozolins, MD, Medical Advisor, Therapeutic Goods Administration, Australia
- Yoshiaki Maruyama, PhD, Review Director, PMDA, Japan
- Mo Heidaran, PhD, VP Technical, PAREXEL, United States
Panel Discussion:
- Rebecca Lim, Ieva Ozolins, Yoshiaki Maruyama, Mo Heidaran
Moderator:
- David Ritchie, Deputy Director, Head, Bone Marrow Transplant Service, Australia
Presenters:
- Steven Oh, PhD, Deputy Director, Office of Tissues and Advanced Therapies, FDA, United States
- So-Young Lee, PhD, Scientific Reviewer, Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety (MFDS), Korea
- Stephan Kadauke, MD, PhD, Assistant Director, Cell and Gene Therapy Lab, CHOP, United States
Panel Discussion:
- David Ritchie, Steven Oh, So-Young Lee, Stephan Kadauke
Moderator:
- Dominic Wall, PhD, FFSc(RCPA), Director of Pathology Operations, Peter MacCallum Cancer Center, Australia
Presenters:
- Rachel Witten, MD, Lead Medical Officer, FDA, United States
- I-Ning Tang, MD, MS, Section Chief of Regulatory Science, Taiwan Center for Drug Evaluation, Taiwan
- Jaap Jan Boelens, MD, PhD, Pediatric Hematologic Oncologist, Chief of Stem Cell Transplantation and Cell Therapy Service, United States
Panel Discussion:
- Dominic Wall, Rachel Witten, I-Ning Tang, Jaap Jan Boelens
Moderator:
- Karen Nichols, Esq., Regulatory and Quality, Magenta Therapeutics, United States
Presenters:
- Judith Arcidiacono, MS, Regulatory Scientist, FDA, United States
- Srinivasan Kellathur, PhD, Head, Advanced Therapy Products Unit, Health Sciences Authority, Singapore
- Francesco Cicirello, PharmD (GPhC, FOPH), MSc, PIC/S Deputy Chair, Therapeutic Goods Administration, Australia
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-ChairCSO Cell Therapies Pty Ltd, Peter MacCallum Cancer Centre, Australia |
Shirley Bartido, PhD, MBADirector of Regulatory Affairs, Cellectis, USA |
Christopher Bravery, PhDDirector, Consulting on Advanced Biologicals, United Kingdom
|
Scott Burger, MDPrincipal, Advanced Cell & Gene Therapy, United States |
Srinivasan Kellathur, PhDHead, Advanced Therapy Products Unit, Health Sciences Authority, Singapore |
Janet Macpherson, PhDProduct Sales Specialist, Cell & Gene Therapy, GE Life Sciences, Australia |