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.
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
29 Nov 2022 @ 08:30 - 30 Nov 2022 @ 17:30
Speaker
![Gulshan Bindra Gulshan Bindra](/images/librariesprovider5/default-album/gkb3.tmb-thumbnail.jpg?Culture=en&sfvrsn=24f1125e_1)
Mr Gulshan Bindra ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Founder and Director
NKG Advisory Business & Consulting Services Pvt. Ltd.
![Karan Bindra Karan Bindra](/images/librariesprovider5/default-album/karan-bindra.tmb-thumbnail.jpg?Culture=en&sfvrsn=b07bc319_1)
Mr Karan Bindra ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Director
Regulatory Compliance and Operations
NKG Advisory Business & Consulting Services Pvt. Ltd.
![Lijoy George Lijoy George](/images/librariesprovider5/default-album/lijoy-george.tmb-thumbnail.png?Culture=en&sfvrsn=8b2cf1fe_1)
Mr Lijoy George ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
AVP, Digital Health
Diagnostics Development Hub (DxD Hub)
![Yasha Huang Yasha Huang](/images/librariesprovider5/default-album/yasha-huang.tmb-thumbnail.jpg?Culture=en&sfvrsn=57b8a71d_1)
Ms Yasha Huang ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Head Regulatory Policy Asia Pacific
Global Regulatory Policy & Intelligence
Roche Diagnostics
![Photograph_Beverly Liew Photograph_Beverly Liew](/images/librariesprovider5/default-album/photograph_beverly-liew.tmb-thumbnail.jpg?Culture=en&sfvrsn=b39fd42e_1)
Ms Beverly Liew ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Senior Regulatory Specialist
Health Sciences Authority
Singapore
![Maria C Matienzo Maria C Matienzo](/images/librariesprovider5/default-album/maria-c-matienzo.tmb-thumbnail.png?Culture=en&sfvrsn=f17b07ef_1)
Ms Maria Cecilia C Matienzo
Director
Center for Device Regulation, Radiation Health and Research
![Nguyen-Hang-Nhi Nguyen-Hang-Nhi](/images/librariesprovider5/default-album/nguyen-hang-nhi.tmb-thumbnail.jpg?Culture=en&sfvrsn=dd92470c_1)
Ms Nguyen Nhi Hang ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Senior Regulatory Affairs Specialist
Andaman Medical Vietnam
![Sumati Randeo Sumati Randeo](/images/librariesprovider5/default-album/sumati-randeo3e6b0a130df94f35931da9ff43bea5b8.tmb-thumbnail.jpg?Culture=en&sfvrsn=9a92459e_1)
Ms Sumati Randeo ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Director
Government Affairs
Danaher Corporation
![Adelheid_Schneider-removebg-preview Adelheid_Schneider-removebg-preview](/images/librariesprovider5/people/adelheid_schneider-removebg-preview.tmb-thumbnail.png?Culture=en&sfvrsn=85035be1_1)
Dr Adelheid Schneider ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Head of Quality and Regulatory Affairs
Roche Diagnostics Asia Pacific
![Winson Teng Winson Teng](/images/librariesprovider5/default-album/profile-photo-winson-teng.tmb-thumbnail.jpeg?Culture=en&sfvrsn=f1e0ed7d_1)
Mr Winson Teng
Manager
Regulatory Affairs Intelligence
BD
![John Thornback John Thornback](/images/librariesprovider5/people/john-thornback.tmb-thumbnail.jpg?Culture=en&sfvrsn=b2c0283_1)
Dr John Thornback ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Senior Advisor
Diagnostics Development Hub (DxD Hub)
Venue