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.
Click here to find out more about the Fees.
The Centre of Regulatory Excellence is an accredited provider for Continuing Professional Education (CPE) for Pharmacists and Continuing Medical Education (CME) for Doctors.
Continuing education credits are available for CoRE events through the Singapore Pharmacy Council and the Singapore Medical Council subject to their respective approvals.
Attendees who wish to avail of the credits are required to sign the relevant registration form along with their CPE/CME number on the day of the events.Should the event be conducted online, please provide your CPE/CME number in the respective e-registration form.
The attendee’s registration details will be submitted after the event and credited upon receiving respective approvals.
Date and Time
07 Feb 2023 @ 08:30 - 08 Feb 2023 @ 17:30
Speaker

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

Mr Khalid Azzouzi 
Global Head of Technical
Research, & Development
AXIUM MTECH

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

Mr Paul Chua
CyberSecurity Officer
Greater Asia
BD

Mr Chris Hardesty 
Strategic Advisor
Asia Pacific Medical Technology Association (APACMed)

Dr Karthik G M 
Regulatory Affairs Lead
(Asia, Middle East and Africa)
Guardant Health Asia

Mr Sheikh Muhd 
Senior Education Associate
Centre of Regulatory Excellence (CoRE)
Duke-NUS Medical School

Ms Tan Tian Ai
Senior Regulatory Specialist
Medical Device Cluster
Health Products Regulation Group
Health Sciences Authorities
Singapore

Mr Kenneth Teo 
Development Manager
ObvioHealth

Mr Hiren Thakkar 
Offering Development Lead
Real World Solution
IQVIA Singapore

Dr Gaston German Westergaard 
Post Market Quality
Sub-Chapter Lead EEA Vigilance
Roche Diagnostics International Ltd

Mr Tibor Zechmeister 
Managing Partner
CommuModo GmbH
Mr Zhuang Guangyi
Senior Regulatory Specialist
Medical Device Cluster
Health Products Regulation Group
Health Sciences Authority
Singapore
Venue