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2022 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


05 Sep 2022 @ 08:30 - 09 Sep 2022 @ 17:30

Speaker


James Chan

Mr James Chan LinkedIn

RA Director
APJI Varian
a Siemens Healthineers company


Sannie_Chong2-removebg-preview
Dr Sannie Chong LinkedIn

Senior Director
MSD Singapore 


Eugene Gan
Dr Eugene Gan

Senior Director
Singapore Clinical Research Institute



Michael Gropp core

Mr Michael Gropp 

Advisory Board Member and Visiting Expert
CoRE
Duke-NUS Medical School

Christine Ho

Ms Christine Ho LinkedIn

Regulatory Consultant
Vigilance & Compliance Branch
Health Sciences Authority
Singapore

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Ms Bernice Lau

Former Medical Device Lead Auditor
TUV SUD 



Murray Lumpkin

Dr Murray Lumpkin LinkedIn

Deputy Director – Integrated Development LeadGlobal Regulatory Systems Initiatives Bill and Melinda Gates Foundation

arun mishra+core

Mr Arun Mishra LinkedIn

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

Kwong Ng_2019

Prof Kwong Ng LinkedIn

Chief HTA Officer
Agency for Care Effectiveness (ACE)
Ministry of Health
Singapore

Sachdeva_Vimal

Mr Vimal Sachdeva 

Technical Officer – Senior Inspector
Inspection Services Group, Prequalification Team (PQT),
World Health Organization (WHO) 


Adelheid_Schneider-removebg-preview
Dr Adelheid Schneider  LinkedIn

Head
Quality and Regulatory Affairs Asia Pacific
Roche Diagnostics Asia Pacific

Geraldine Seow

Ms Geraldine Seow LinkedIn

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

Sharad Shukla

Mr Sharad Shukla LinkedIn

Director Regulatory Affairs
MedTech Regulatory Affairs
Southeast Asia
Johnson & Johnson MedTech

Lucky_crop

Dra Lucky Slamet

Visiting Expert
CoRE
Duke-NUS Medical School 

Thean Soo Lo

Mr Thean Soo LinkedIn

Regulatory Affairs Management Consultant
TS Consulting 

Stephen Sunderland

Mr Stephen Sunderland LinkedIn

Partner, Head of SE Asia Healthcare and Life Science
L.E.K. Consulting

John Thornback

Dr John Thornback LinkedIn

Senior Advisor
Diagnostics Development Hub (DxD Hub)