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2024 GMS5005 Regulation of Advanced Therapies

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 course 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 course 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


15 Apr 2024 @ 08:30 - 19 Apr 2024 @ 17:30

Speaker


 

Mathew Adams

Mr Junaidi Abu 

Regulatory Consultant (GMP)
Audit & Licensing Division
Health Products Regulation Group
Health Sciences Authority
Singapore


Judith Arcidiacono

Ms Judith Arcidiacono Linkedin logo

International Regulatory Expert
Center for Biologics Evaluation and Research
Office of Therapeutic Products
U.S. Food and Drug Administration 


Fouad Atouf

Dr Fouad Atouf Linkedin logo

Senior Vice President
Global Biologics
The United States Pharmacopeial Convention  

Dr Sudipto Bari

Dr Sudipto Bari Linkedin logo

Head & Assistant Director
Translational Services & Regulatory Management
Advanced Cell Therapy and Research Institute
Singapore 


Marieta Chan

Dr Natasha Brockwell Linkedin logo

Director
Indo-Pacific Regulatory Strengthening Program
Therapeutic Goods Administration
Australia


Patrick Celis

Dr Patrick Celis Linkedin logo

Lead Scientific Officer
Committee for Advanced Therapies
European Medicines Agency

Lucas Chan
Dr Lucas Chan Linkedin logo

Scientific Founder & Chief Scientific Officer
CellVec
Singapore

Paul TK Goh

Mr Paul TK Goh Linkedin logo

National Business Development Manager                             
World Courier
Singapore

Christine Ho

Ms Christine Ho Linkedin logo

Deputy Director
Advanced Therapy Products Branch
Health Sciences Authority
Singapore


Liang Lin

Ms Liang Lin Linkedin logo

Deputy Director / Senior Lead Specialist
Value-based Pricing and Gene Therapy Evaluation
Agency for Care Effectiveness
Ministry of Health
Singapore

Francesca Lim

Dr Francesca Lorraine Lim Linkedin logo

Senior Consultant Haematologist
Singapore General Hospital
Chief Medical Officer
Advanced Cell Therapy and Research Institute
Singapore

Dr Yusuke Nozaki

Dr Yusuke Nozaki

Reviewer
Office of Cellular and Tissue-based Products
Pharmaceuticals and Medical Devices Agency
Japan

Bernice Oh

Dr Bernice Oh Linkedin logo

Consultant
Division of Paediatric Haematology and Oncology
National University Hospital 


Dr Lee Lee Ong

Dr Lee Lee Ong Linkedin logo

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


Phua Chwee Ping

Ms Phua Chwee Ping Linkedin logo

Regional Head of Patient Safety
Asia Pacific
Novartis


 

Dr Kellathur Srinivasan 2

Dr Anuradha Rajapakse

Senior Director
Market Access & Reimbursement
Gilead

Attila Sebe

Dr Attila Sebe Linkedin logo

Scientist and Clinical Assessor for ATMPs
Paul-Ehrlich-Institut (PEI)
Federal Institute for Vaccines and Biomedicines
Germany

Dr Kellathur Srinivasan 2

Dr Kellathur Srinivasan Linkedin logo

Regional Regulatory Policy Lead APAC
Roche
Singapore

Calvin Tan

Mr Calvin Tan Linkedin logo

Customer Success Project Coordinator
World Courier


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Dr Dorothy Toh Su Lin

Assistant Group Director
Medicinal Products Pre-market Cluster
Health Sciences Authority
Singapore

Steve Winitsky

Dr Steve Winitsky 

Vice President - Technical
Parexel Consulting
United States

Xiaofeng Wu

Dr Xiaofeng Wu 

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

Venue