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2021 GMS5107 In Vitro Diagnostic Devices and Precision Medicine (Conducted Remotely)

In Vitro Diagnostic Medical Devices (IVDs) are a key component of healthcare, and pivotal to advancing technology solutions for patient centric care, such as precision medicine and companion diagnostics. This module covers an overview of the technical documentation and available international standards for IVDs, providing a fundamental understanding of the principles behind effective regulation of IVDs.

This module provides a foundation of the regulatory principles governing IVDs and their use in precision medicine alongside companion diagnostics. It also provides an introduction to standards and guidelines playing a pivotal role in meeting requirements to ensure product safety, quality and performance.

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

 
 




Date and Time


04 Oct 2021 @ 08:30 - 08 Oct 2021 @ 17:30

Registration


Registration is closed

Speaker


Adelheid_Schneider

Dr Adelheid Schneider

Head
Regulatory and Quality Asia Pacific
Roche Diagnostics Asia Pacific

Carly McWilliams

Ms Carly McWilliams

Head of Regulatory Policy
Roche

Danny Ong

Mr Danny Ong

Senior Regulatory Specialist
Medical Devices Branch
Health Sciences Authority
Singapore


Mr Jack Wong

International Medical Device School
Singapore


Mr Jason Lim

CEO & Co-founder
The Stendard Team

John Thornback

Dr John Thornback

Chief Operating Officer
Diagnostics Development Hub (DxD Hub)

Kelsan Bastari

Dr Kelsen Bastari

Senior Regulatory Specialist
Medical Devices Branch
Health Sciences Authority
Singapore

Low Lai Peng

Ms Low Lai Peng

Deputy Director
Medical Devices Branch
Health Sciences Authority
Singapore

Lubna Syed

Ms Lubna Syed

Global Director
Regulatory Affairs
Janssen



Ms May Ng

International Medical Device School
Singapore

Melissa Robins

Dr Melissa Robins

Regulatory Affairs Manager
BD Life Sciences
Australia and New Zealand

Ong Ming Hao

Mr Ming Hao Ong

Senior Regulatory Specialist
Health Sciences Authority
Singapore


Mr Nichol Lim

QA/RA Consultant
The Stendard Team

Shaqireen Moinuddeen

Dr Shaqireen Moinuddeen

Senior Regulatory SpecialistMedical Devices Cluster
Health Sciences Authority
Singapore

Rahul Pandey

Dr Rahul Pandey

Principal Manager
Diagnostics Development (DxD) Hub

Varun_Veigas no bg

Mr Varun Veigas

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

Yasha Huang

Ms Yasha Huang

Regional Regulatory Affairs and Policy Lead
Regional VDR Program Lead
Roche Diagnostics Asia Pacific