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2020 GMS5104 Biotherapeutics and Biosimilars (Conducted Remotely)

The advent of biotherapeutics and biosimilars highlighted the need for regulatory affairs to accommodate the evolving medical sciences, necessitating timely revisions in policies, processes and the technical knowledge in managing these new innovations and facilitating access to meet medical needs. This course provides the background to the rise of these biologicals in healthcare, the defining differences from traditional pharmaceuticals and generics, and the regulatory processes for managing these health products. There is a focus on post-market activities which serve as the main guard for ensuring the safe use of these innovations.

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



 


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Date and Time


02 Nov 2020 @ 09:00 - 06 Nov 2020 @ 18:00

Speaker


Andrew 2020
Dr Andrew Green

Head
Medical Affairs
Takeda

Anne Cook2

Dr Anne Cook

Expert Quality Assessor
Medicines and Healthcare products Regulatory Agency (MHRA)
London, UK 


Chris Pashos
Dr Chris Pashos 

Chief Scientific Officer
Genesis Research

Cynthia Sung

Dr Cynthia Sung

Portfolio & Platform Lead
Translational Sciences
Maternal Neonatal and Child Health
Bill & Melinda Gates Medical Research
Greater Seattle Area

inger mollerup_2

Ms Inger Mollerup

Regulatory Consultant
Inger Mollerup Regulatory Consulting 
Denmark

Jacqueline Berman

Ms Jacqueline R. Berman

Legal Partner
Morgan Lewis Stamford LLC


Julia Katherine Maier

Dr Julia Katharina Maier

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

Martin Schiestl

Dr Martin Schiestl

Head
Regulatory Affairs Policy & Intelligence
Sandoz Biopharmaceutica

Ooi Eng Eong

Prof Ooi Eng Eong

Professor and Deputy Director
Programme in Emerging Infectious Diseases
Duke-NUS Medical School
Co-Director
Viral Research and Experimental Medicine Centre
SingHealth Duke-NUS Academic Medical Centre 

Paul Ranson

Mr Paul Ranson

Consultant
Morgan, Lewis & Bockius LLP

Sannie Chong2

Dr Sannie Chong

Asia Pacific Technical Regulatory Policy
Global Regulatory Policy Group
Roche Singapore Technical Operations Pte Ltd

Todd Esker

Mr Todd Esker

Partner
Morgan, Lewis & Bockius LLP

Vidhya Hariraj
Dr Vidhya Harijaj

Pharmacist from Pharmacovigilance Section
Centre of Compliance and Quality Control
National Pharmaceutical Regulatory Agency (NPRA)

William Hwang_core

Prof William Hwang

Medical Director
National Cancer Centre
Senior Consultant, Department of Haematology
Singapore General Hospital

Yusdy Pan

Dr Yusdy Pan

Director
Process Development
Amgen Singapore Manufacturing


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