2022 Executive Certificate Workshop: Regulation of In Vitro Diagnostic Devices (Conducted Face-to-Face)

In Vitro Diagnostic (IVD) devices are a key component of healthcare, and pivotal to advancing technology solutions for patient centric care, such as personalized medicine. These devices are not limited to only healthcare professionals’ use, but some are also widely and directly available for consumers. This highlights the importance of effective regulation of IVD, ensuring their safety, quality and performance in supporting the healthcare system, patients and consumers. This course will provide a fundamental understanding of the principles behind effective regulation of IVD devices, and cover an overview of the technical documentation and available international standards. This enables an informed decision when planning for the development, market entry and management of IVD devices.

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


Date and Time

29 Nov 2022 @ 08:30 - 30 Nov 2022 @ 17:30


Gulshan Bindra

Mr Gulshan Bindra LinkedIn

Founder and Director
NKG Advisory Business & Consulting Services Pvt. Ltd.

Karan Bindra

Mr Karan Bindra  LinkedIn

Regulatory Compliance and Operations 
NKG Advisory Business & Consulting Services Pvt. Ltd.

 Lijoy George

Mr Lijoy George  LinkedIn

AVP, Digital Health
Diagnostics Development Hub (DxD Hub)

Yasha Huang

Ms Yasha Huang LinkedIn

Head Regulatory Policy Asia Pacific
Global Regulatory Policy & Intelligence
Roche Diagnostics 

Photograph_Beverly Liew
Ms Beverly Liew LinkedIn

Senior Regulatory Specialist
Health Sciences Authority

Maria C Matienzo
Ms Maria Cecilia C Matienzo

Center for Device Regulation, Radiation Health and Research


Ms Nguyen Nhi Hang LinkedIn

Senior Regulatory Affairs Specialist
Andaman Medical Vietnam

Sumati Randeo

Ms Sumati Randeo LinkedIn

Government Affairs  
Danaher Corporation


Dr Adelheid Schneider LinkedIn

Head of Quality and Regulatory Affairs
Roche Diagnostics Asia Pacific

Winson Teng

Mr Winson Teng LinkedIn   

Regulatory Affairs Intelligence

John Thornback

Dr John Thornback LinkedIn

Senior Advisor
Diagnostics Development Hub (DxD Hub)