Duke-NUS Centre of Regulatory Excellence - Courses

CALENDAR 2024 

 Course Name   Date   Registration   Fees

  Graduate Certificate in Health Products Regulation:
  GMS5005 Regulation of Advanced Therapies

  15 to 19 April 2024

  1 Nov 2023 - 30 Jan 2024


 SGD5400*
per course
(before GST)

SSG Approved

*Click here for
more details on
SSG funding


With effect from 1 January 2024, individuals using credit/debit card and eWallet  to make payment via NUSFastPay will have to pay a 1processing fee

No processing fee is charged for using PayNow QR and Convera in NUSFastPay.

  Graduate Certificate in Health Products Regulation:
  GMS5114 Post-Market for Medical Technologies
  6 to 10 May 2024   1 Nov 2023 - 1 Apr 2024
  Graduate Certificate in Medical Technology Regulation:
  GMS5008 Regulation and Clinical Evaluation of
  Medical Devices
     
  12 to 16 Aug 2024   13 May 2024 - 1 July 2024
  Graduate Certificate in Pharmaceutical Regulation:
  
GMS5003 Fundamentals of Health Products Regulation
  9 to 13 Sept 2024   1 April 2024 - 1 July 2024
  Graduate Certificate in Pharmaceutical Regulation:
  GMS5004 Regulation of Pharmaceutical Manufacturing
  11 to 15 Nov 2024   1 April 2024 - 1 July 2024
  Graduate Certificate in Medical Technology Regulation:
  GMS5009 Manufacturing and Quality Management
  System for Medical Devices
     
  2 to 6 Dec 2024   1 July 2024 - 4 October 2024
  Graduate Certificate in Medical Technology Regulation:
  GMS5106 Regulation of Digital Health Products
  To be advised   To be advised
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Graduate Certificate in Pharmaceutical Regulation

GMS5003
Fundamentals of Health Products Regulation

(4 units)

This course lays the foundational basis of regulatory management and decision-making for health products, and covers the essential principles in managing pharmaceuticals and medical devices across their life cycles.

GMS5004
Regulation of Pharmaceutical Manufacturing

(4 units)

This course provides the foundation in understanding the regulatory science behind the development, manufacturing and control of pharmaceuticals, including the global guidances that shape the regulatory processes.

GMS5108
Clinical Studies & Evaluation of Health Products

(4 units)

This course will provide an overview of the design and phases of human clinical trials, as well as the regulatory requirements to support market approvals of pharmaceuticals, medical devices and technologies.

GMS5116
Post-Market Activities for Pharmaceuticals

(4 units)

This course will allow participants to understand the damaging implications of poor quality medicines to public health, as well as the evolving challenges in minimising the entry of these substandard medicines and falsified products.

Graduate Certificate in Medical Technology Regulation

GMS5008
Regulation and Clinical Evaluation of Medical Devices

(4 units)

This course describes the unique approaches for the product design and development, as well as regulation of medical devices and technology. Key concepts for assessing the clinical performance of medical devices will be introduced, facilitating the understanding of an optimal environment for health technology adoption.

GMS5009
Manufacturing and Quality Management System for Medical Devices

(4 units)

This course covers the production, quality management systems, and regulatory activities related to quality assurance of medical technology in regulated markets.

GMS5114
Post Market for Medical Technologies

(4 units)

This course aims to equip students with the knowledge of the post-market regulatory requirements of medical devices, and the activities involved in managing adverse events and conducting Field safety corrective action.

GMS5106
Regulation of Digital Health Products

(4 units)

Through this course, students will learn to describe and differentiate the relevant standards and guidance required in Digital Health products verification and validation.

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