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2023 Executive Certificate Workshop: Post-market vigilance: Regulatory activities for monitoring IVD and SaMD (Conducted Face-to-Face)

As new medical devices and technologies enter into the healthcare system at an exceedingly fast speed, it is important that the safety, quality and effective performance of these innovations comply with required standards throughout their product life cycle. Coverage of safety starts from the designing of the medical devices. Thus, having good post-market vigilance practices is essential to safeguard the public health. This course aims to provide an overview of the post-market processes for monitoring the safety and effective performance of medical devices, including healthcare softwares and applications, as well as complying with requirements for changes and updates to the products after regulatory approvals. Participants will have an insight into the interactions among regulatory organisations that guide professionals for good practices in post-market surveillance.

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

 


Date and Time


07 Feb 2023 @ 08:30 - 08 Feb 2023 @ 17:30

Speaker



Sundeep Agarwal
Mr Sundeep Agarwal LinkedIn

Vice President – Regulatory Affairs & Quality Assurance
Remidio Innovative Solutions Pvt. Ltd.

Khalid Azzouzi

Mr Khalid Azzouzi LinkedIn

Global Head of Technical
Research, & Development
AXIUM MTECH


Hishamuddin Badaruddin-01_jpg_CoRE

Dr Hishamuddin Badaruddin LinkedIn

Adjunct Assistant Professor
Chief Medical Officer
Chi Tree Longevity
Medical Advisory Board Member
Chi Tree Health

Paul Chua

Mr Paul Chua 

CyberSecurity Officer
Greater Asia
BD

Chris Hardesty

Mr Chris Hardesty LinkedIn

Strategic Advisor
Asia Pacific Medical Technology Association (APACMed)

Karthik G M

Dr Karthik G M LinkedIn

Regulatory Affairs Lead
(Asia, Middle East and Africa)
Guardant Health Asia

Tan Tian Ai

Ms Tan Tian Ai 

Senior Regulatory Specialist
Medical Device Cluster
Health Products Regulation Group
Health Sciences Authorities 
Singapore

Kenneth Teo

Mr Kenneth Teo LinkedIn

Development Manager
ObvioHealth

Hiren Thakkar

Mr Hiren Thakkar LinkedIn

Offering Development Lead
Real World Solution
IQVIA Singapore

Gaston German Westergaard

Dr Gaston German Westergaard LinkedIn

Post Market Quality
Sub-Chapter Lead EEA Vigilance
Roche Diagnostics International Ltd

Tibor Zechmeister

Mr Tibor Zechmeister LinkedIn

Managing Partner
CommuModo GmbH


Zhuang Guangyi 

Mr Zhuang Guangyi

Senior Regulatory Specialist
Medical Device Cluster
Health Products Regulation Group
Health Sciences Authority
Singapore

Venue