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2021 GMS5103 Regulation of Cell, Tissue and Gene Therapies (Conducted Remotely) - Re-run

Advanced therapies, covering the scope of cellular, tissue and gene treatment modalities, is a rapidly advancing field that offers exciting new therapeutic possibilities and constantly challenges the regulatory environment to expedite access to these innovations. Through this module, an understanding is gained on the various frameworks and practices regulating advanced therapies, including requirements for product evaluation and dossier submission for an effective product life cycle management. The module will interest students who are keen in global trending regulatory approaches and strengthening the skill sets to accommodate new innovation. There is also a focus on promoting convergence of regulatory approaches for advanced therapies.

Registration is currently closed due to full capacity. If you would like to be considered for a place on the waitlist, please write to us at core_education@duke-nus.edu.sg

 
 

Click here for a step by step guide on how to register.

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Date and Time


18 Jan 2021 @ 09:00 - 22 Jan 2021 @ 18:00

Speaker


Fouad Atouf

Dr Fouad Atouf 

Vice President 
Science - Global Biologics 
The United States Pharmacopeial Convention (USP)

Steve Winitsky

Dr Steve Winitsky 

Vice President 
Technical 
Paraxel Consulting

Katherine A. TSOKAS, JD

Ms Katherine Tsokas

Vice President
Regulatory
Risk Management & Drug Safety
Janssen

Chin KOERNER

Ms Chin Koerner 

Executive Director 
US Regulatory and Development Policy 
Novartis 

Martina Schuessler-Lenz

Dr Martina Schüssler-Lenz

Chair
EMA Committee for Advanced Therapies
Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines



Patrick Celis

Dr Patrick Celis

Scientific Administrator (CAT Secretariat) European Medicines Agency (EMA)

Judith Arcidiacono

Ms Judith Arcidiacono

International Regulatory Expert and 
Standards Development Liaison Office
Cellular Tissue and Gene Therapy 
U.S. Food and Drug Administration (US FDA)


Tan Lip Kun

Dr Tan Lip Kun

Senior Consultant and Medical Director
Tissue Engineering & Cell Therapy Laboratory
National University Hospital (NUH), Singapore

Tony Maderson

Dr Tony Manderson

Principal Advisor 
Cell & Tissue Therapies Unit 
Therapeutic Goods Administration (TGA)

Yoshiaki MARUYAMA, PhD

Dr Yoshiaki Maruyama

Review Director 
Office of Cellular and Tissue-based 
Pharmaceuticals and Medical Devices Agency (PMDA)

Jessica Teo

Ms Jessica Teo

Director
Audit and Licensing Division
Health Sciences Authority (HSA)

Srinivasan KELLATHUR

Dr Kellathur Srinivasan

Director 
Advanced Therapy Products Branch
Health Sciences Authority (HSA)

Azizah Ab Ghani

Dr Azizah Abd Ghani

Head of Biologic Section 
National Pharmaceutical Regulatory Agency
Malaysia

Snehal

Dr Snehal Naik 

Regulatory Head 
Regenerative Medicine & Advanced Therapy 
Johnson & Johnson


Marieta Chan

Dr Marieta Chan

Laboratory Director & 
Consultant Scientist Health Sciences Authority (HSA)

Phua Chwee Ping

Ms Phua Chwee Ping

Head of Patient Safety
Regional PVO Manager
AMAC
Novartis

Xiaofeng Wu

Dr Xiaofeng Wu

Regulatory Consultant
Innovation Office and Clinical Trials Branch
Health Sciences Authority (HSA)

Elaine Tang

Dr Elaine Tang

Senior Regulatory Specialist (GMP)
Audit & Licensing Division, HPRG
Health Sciences Authority (HSA)

ong lee lee

Dr Lee Lee Ong

Senior Regulatory Specialist 
Health Sciences Authority (HSA)

Xiangliang Lin

Mr Xiangliang Lin

Founder and President 
Esco Healthcare 

Rahul Pandey

Dr Rahul Pandey

Healthcare Consultant 
Clarivate Analytics 

Lucas Chan


Dr Lucas Chan

Co-founder
CSO CellVec


Wittawat Viriyabancha_core

Mr Wittawat Viriyabancha

PharmacistBiological Product Unit
Pre-marketing Control Division 
Bureau of Drug Control
Thailand Food and Drug Administration

Anthony Tan

Dr Anthony Tan

Senior Research Fellow 
Duke-NUS Medical School