Speaker
- Srinivasan KellathurHead,
Advanced Therapy Product Unit,
Health Products Regulation Group,
Health Sciences Authority (HSA) -
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Day 1 ▶ Opening
- Overview of workshop
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Day 1 ▶ Opening
- Katherine TsokasRegulatory Head,
Regenerative Medicine & Advance Therapy,
Janssen R&D -
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Day 1 ▶ Session 1
- Pitfalls and upcoming challenges in development and regulation of Advanced Therapies: An Industry Perspective
-
Day 1 ▶ Session 1
- Wilson BryanDirector,
Office of Tissue and Advanced Therapies,
US Food and Drug Administration (US FDA) -
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Day 1 ▶ Session 2
- Update on the US FDA framework
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Day 1 ▶ Session 2
- Ilona ReischlVice-Chair,
Committee for Advanced Therapies,
European Medicines Agency (EMA) -
-
Day 1 ▶ Session 2
- Update on the EMA framework
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Day 2 ▶ Session 3
- Trials for Advanced Therapies
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Day 1 ▶ Session 2
- Tony MandersonPrincipal Advisor,
Biological Science, Scientific Evaluation Branch,
Therapeutic Goods Administration (TGA) -
-
Day 1 ▶ Session 2
- Understanding the Australia’s TGA and Health Canada’s framework for regulating Advanced Therapies
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Day 1 ▶ Session 2
- Kasai MasakiPrincipal Reviewer,
Pharmaceuticals and Medical Devices Agency (PMDA) -
-
Day 1 ▶ Session 2
- Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Japan
-
Day 1 ▶ Session 2
- Jeewon JoungDirector,
Cell and Gene Therapy Products Division,
Ministry of Food and Drug Safety (MFDS) -
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Day 1 ▶ Session 2
- Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Korea
-
Day 1 ▶ Session 2
- Azizah Ab GhaniSenior Principal Assistant Director,
Head of Biologics Section,
National Pharmaceutical Regulatory Agency (NPRA) -
-
Day 1 ▶ Session 2
- Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Malaysia
-
Day 1 ▶ Session 2
- Ong Lee LeeSenior Regulatory Specialist,
Advanced Therapy Products Unit,
Health Products Regulation Group,
Health Sciences Authority (HSA) -
-
Day 1 ▶ Session 2
- Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Singapore
-
Day 1 ▶ Session 2
- Lucas ChanDirector,
GMP Manufacture and Development,
Stem Med Ltd -
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Day 2 ▶ Session 3
- Overview of the development of Advanced Therapies
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Day 2 ▶ Session 3
- Antonio LeeCEO & Managing Director,
Medipost America Inc -
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Day 2 ▶ Session 3
- Cell Master File - A novel concept
-
Day 2 ▶ Session 3
- Marieta ChanLaboratory Director,
Blood Service Group,
Health Sciences Authority (HSA) -
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Day 2 ▶ Session 4
- GMP Requirements for Advanced Therapies: Industry’s perspective
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Day 2 ▶ Session 4
- Goh Choon WeeRegulatory Consultant, Senior GMP Inspector,
Audit & Licensing Division,
Health Sciences Authority (HSA) -
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Day 2 ▶ Session 4
- GMP Requirements for Advanced Therapies: Regulator’s perspective
- Case Discussion
-
Day 2 ▶ Session 4
- Foaud AtoufVice President,
Global Biologics - Sciences & Standards,
US Pharmacopeial Convention (USP) -
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Day 2 ▶ Session 4
- USP standards for Cell and Tissue Therapies
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Day 2 ▶ Session 4
- Tamra LysaghtCentre for Biomedical Ethics,
Yong Loo Lin School of Medicine,
National University of Singapore -
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Day 3 ▶ Session 5
- Ethical considerations in Advanced Therapies
- Panel Discussion
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Day 3 ▶ Session 5
- Gayatri SharmaExecutive Director,
Yuki Bioscience Pte Ltd -
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Day 3 ▶ Session 5
- From Research to Market: An entrepreneur’s perspective on impacting healthcare
- Panel Discussion
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Day 3 ▶ Session 5
- Toh Han ChongSenior Consultant, Deputy Director
National Cancer Centre, Singapore -
-
Day 3 ▶ Session 5
- Stakeholders’ Perspective - Practitioners
- Panel Discussion
-
Day 3 ▶ Session 5
