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2022 GMS5005 Regulation of Advanced Therapies (Conducted Remotely)

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. 

This module provides a better understanding of 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 skillsets to accommodate new innovation. There is also a focus on promoting convergences of regulatory approaches for advanced therapies.

Due to the limited availability of seats, early registration is strongly recommended.
 
 



Date and Time


21 Mar 2022 @ 08:30 - 25 Mar 2022 @ 17:30

Speaker


Mathew Adams

Dr Mathew Adams 

Departmental Officer
Biological Science Section
Scientific Evaluation Branch
Therapeutic Goods Administration
Australia


Judith Arcidiacono

Ms Judith Arcidiacono Linkedin logo

International Regulatory Expert and
Standards Development Liaison
Office of Cellular Tissue and Gene Therapy
U.S. Food and Drug Administration 

Fouad Atouf

Dr Fouad Atouf Linkedin logo

Vice President
Science—Global Biologics
The United States Pharmacopeial Convention  

Sudipto Bari

Dr Sudipto Bari Linkedin logo

Senior Research Fellow,
National Cancer Centre
Singapore

Lucas Chan
Dr Lucas Chan Linkedin logo

Co-founder CSO
CellVec

Marieta Chan

Dr Marieta Chan Linkedin logo

Laboratory Director & Consultant Scientist 
Health Sciences Authority
Singapore

Patrick Celis

Dr Patrick Celis Linkedin logo

Scientific Administrator (CAT Secretariat)
European Medicines Agency

Azizah Ab Ghani

Dr Azizah Abd Ghani

Head of Biologic Section                             
National Pharmaceutical Regulatory Agency
Malaysia

Francesca Lim

Dr Francesca Lorraine Lim Linkedin logo

Senior Consultant Hematologist
Singapore General Hospital
Assistant Medical Director
Cell Therapy Facility
Health Science Authority
Singapore


Shinichi Noda
Dr Shinichi Noda Linkedin logo

Deputy Review Director
Office of Cellular and Tissue-based 
Pharmaceuticals and Medical Devices Agency
Japan

Bernice Oh

Dr Bernice Oh 

Consultant
Division of Paediatric Haematology and Oncology
National University Hospital 


ong lee lee

Dr Lee Lee Ong  

Regulatory Consultant
Advanced Therapy Products Branch
Health Products Regulation Group
Health Sciences Authority
Singapore

Phua Chwee Ping

Ms Phua Chwee Ping Linkedin logo

Head of Patient Safety
Regional PVO Manager
AMAC
Novartis


Martina Schuessler-Lenz

Dr Martina Schüssler-Lenz 

Chair
EMA Committee for Advanced Therapies
Paul-Ehrlich-Institut (PEI)
Federal Institute for Vaccines and Biomedicines
Germany


Srini_core

Dr Kellathur Srinivasan Linkedin logo

Director
Advanced Therapy Products Branch
Health Sciences Authority
Singapore

Lawrence Stark

Dr Lawrence Starke Linkedin logo

Global Unit Head
Regulatory Affairs (CMC)
Cell & Gene Therapy
Novartis

Tan Lip Kun

Dr Tan Lip Kun 

Senior Consultant and Medical Director
Tissue Engineering & Cell Therapy Laboratory
National University Hospital 
Singapore


Elaine Tang

Dr Elaine Tang 

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

Katherine A. TSOKAS, JD

Ms Katherine Tsokas  Linkedin logo

Vice President Regulatory,
Quality Risk Management & Drug Safety
Janssen, Canada

Steve Winitsky

Dr Steve Winitsky 

Vice President - Technical
Paraxel Consulting

Xiaofeng Wu

Dr Xiaofeng Wu 

Regulatory Consultant
Innovation Office and Clinical Trials Branch
Health Sciences Authority
Singapore


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