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2020 GMS5103 Regulation of Cell, Tissue and Gene Therapies (Conducted Remotely)

In view of the COVID-19 situation and the local measures to further contain the spread, GMS5103 Regulation of Cell, Tissue and Gene Therapies (22-26 June 2020) will be conducted remotely:

The workshop programmes has been re-arranged to accommodate the logistics involved. Students will require a laptop or computer with a video camera and internet access for the duration of the workshop.

We seek your kind understanding on the necessary changes to deliver the same quality of our programmes to you, and your continued support to CoRE and measures to counter COVID19. Should you have any queries, kindly contact us at CoRE_Education@duke-nus.edu.sg


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.

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

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

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 Registration is closed. Thank you for your support. 

 

   

Date and Time


22 Jun 2020 @ 09:00 - 26 Jun 2020 @ 17:00

Registration


Registration is closed

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

Mo Heidaran

Dr Mo Heidaran

Vice President
Technical
Regulatory and Technical CMC
Paraxel Consulting

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)

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)

Christine Ho

Ms Christine Ho

Regulatory Consultant
Vigilance & Compliance Branch
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