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2020 Workshop: Regulation of Software as a Medical Device (Conducted Remotely)

In today’s digital world, technologies and software play an increasingly important role in healthcare management - diagnosis, treatment, patient monitoring and Real World Data collection. While software as a Medical Device is currently controlled via medical device regulation, they differ significantly from traditional medical devices and require a more streamlined and efficient regulatory oversight. This workshop provides a fundamental understanding of software standards and guidelines, which are important tools for the effective governance of SaMDs.

 


         




Date and Time


01 Dec 2020 @ 08:30 - 02 Dec 2020 @ 17:30

Speaker


John Thornback
Dr John Thornback

Chief Operating Officer
Diagnostics Development (DxD) Hub


Yuri A. Maricich

Dr Yuri A. Maricich

Chief Medical Officer 
and Head of Development
Pear Therapeutics

Praveen Raj Kumar

Mr Praveen Raj Kumar

Senior Assistant Director 
Engagement and Strategy
Health Regulation Group 
Ministry of Health, Singapore

 

Nate-Carrington
 
Dr Nathan Carrington

Head of Digital Health and Innovation
Global Regulatory Policy and Intelligence
Roche Diagnostics

 

Varun_Veigas

Mr Varun Veigas

Regional Regulatory Affairs & 
Policy Lead Asia Pacific 
Roche Diagnostics Asia Pacific Pte. Ltd

Lesley Maloney

Dr Lesley Maloney

Regulatory Policy Lead
Digital Health International Regulatory Policy
Product Development Regulatory Genentech

Manan Hathi

Mr Manan Hathi

Senior Manager Regulatory Affairs
Software
Stryker

Roberta Sarno

Dr Roberta Sarno

Manager
Digital health and Clinical & Medical affairs
Asia Pacific Medical Technology Association (APACMed)

Paul Chua

Mr Paul Chua

Cyber Security Officer
Greater Asia, BD

Su Jinyao

Mr Su Jinyao

Regulatory Affairs Manager
Diagnostic Development (DxD) Hub

 

LIN ANLE

Mr Lin Anle

Senior Regulatory Specialist
Medical Devices Branch
Health Sciences Authority

Siew Jie Yee

Ms Siew Jie Yee

Senior Regulatory Specialist 
Medical Devices Branch 
Health Sciences Authority
Singapore


Zhuang Guangyi

Mr Zhuang Guangyi

Senior Regulatory Specialist 
Medical Devices Branch 
Health Sciences Authority
Singapore