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2021 GMS5003 Fundamentals of Health Products Regulation (Conducted Remotely)

Regulation of health products is controlled by standards, guidelines and legal frameworks. The interactions among these and the stakeholders – industry, regulatory authorities, healthcare professionals and patients – are required for effective governance for timely access and safe, quality and efficacious medicines and medical devices for patients. 

This fundamental module provides the understanding of the contribution of the various stakeholders, functions and guidelines that shape the regulatory environment and impact the healthcare management scene. The concept of product life cycle will be also be explored among other contemporary regulatory approaches. 


 
 
 

 


Date and Time


08 Nov 2021 @ 08:30 - 12 Nov 2021 @ 17:30

Registration


Registration closed

Speaker


Adelheid_Schneider-removebg-preview

Dr Adelheid Schneider

Head
Quality and Regulatory Affairs Asia Pacific
Roche Diagnostics Asia Pacific

arun mishra+core

Mr Arun Mishra

Head, Global Nutrition Regulatory Affairs and
Global Health and Wellness Regulatory Affairs
Unilever

Christine Ho

Ms Christine Ho

Regulatory Consultant
Vigilance & Compliance Branch
Health Sciences Authority



Geraldine Seow
Ms Geraldine Seow

Director, Global Program LeaderMedical Affairs Operation, Asia Pacific
Global Development, Janssen R&D
The Janssen Pharmaceutical Companies of Johnson & Johnson


Mr Jason Lim

CEO & Co-founder
Stendard

John Thornback

Dr John Thornback

Senior Advisor
Diagnostics Development Hub (DxD Hub)

Hsien-Yi Lin
Dr Lin Hsien-Yi

Senior Reviewer
Division of Medicinal Products
Taiwan Food and Drug Administration

Lucky_crop

Dra Lucky Slamet

Visiting Expert
CoRE, Duke-NUS Medical School


Mr Nichol Lim

QA/RA Consultant
Stendard

Nishith Desai

Mr Nishith Desai

Vice-President of QA and RA, APAC
Medtronic

Michael Gropp core

Mr Michael Gropp

Advisory Board Member and Visiting Expert
CoRE, Duke-NUS Medical School
Former Chair
RAPS Global Advisory Council

Murray Lumpkin

Dr Murray Lumpkin

Deputy Director – Integrated Development
Lead for Global Regulatory Systems Initiatives
Bill and Melinda Gates Foundation

Sannie Chong2

Dr Sannie Chong

Asia Pacific Technical Regulatory Policy
Global Regulatory Policy GroupRoche Singapore Technical Operations Pte Ltd

Sharad Shukla

Mr Sharad Shukla

Head
Regulatory Affairs SEA (MD&D)
Johnson & Johnson


Sachdeva_Vimal

Mr Vimal Sachdeva

Technical Officer – Senior Inspector
Inspection Services Group, Prequalification Team (PQT)
Regulation of Medicines and other Health Technologies (RHT)
World Health Organization (WHO)

Yu Liang

Mr Yu Liang

Associate Director
Regulatory Affairs CMC APAC
MSD