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Duke-NUS Centre of Regulatory Excellence - Modules

CALENDAR 2022-2023

As of July 2021, the following changes are applicable to the Graduate Certificate in Health Products Regulation.

Old Module Name  New Module Name From July 2021 onwards Date  Registration   Fees
GMS5011 Fundamentals of Pharmaceutical Regulation

GMS5003 Fundamentals of Health Products Regulation

5 to 9 Sep 2022

Closed

  SGD5400*
(before GST)

SSG Approved

*Click here for
more details on
SSG funding

GMS5104 Biotherapeutics and Biosimilars 

GMS5006 Regulation of Biotherapeutics and Biosimilars

7 to 11 Nov 2022

Closed

GMS5012 Chemistry, Manufacturing and Controls

GMS5004 Regulation of Pharmaceutical Manufacturing

6 to 10 Mar 2023

Closed

GMS5111 Pharmacovigilance: Principles and Frameworks

GMS5115 Principles and Frameworks for Pharmacovigilance 

 10 to 14 Apr 2023
 Registration closes on 3 Feb 2023

GMS5011 Fundamentals of Pharmaceutical Regulation

GMS5003 Fundamentals of Health Products Regulation

21 to 25 Aug 2023

8 May to 26 May 2023

GMS5113 Post-market Surveillance and Enforcement

GMS5116 Post-Market Activities for Pharmaceuticals

25 to 29 Sep 2023

 8 May to 26 May 2023

No change

GMS5106 Regulation of Digital Health Products New!

30 Oct to 3 Nov 2023

10 Jul - 28 Jul 2023

CLICK ON THE COURSES BELOW TO LEARN MORE

 Fundamentals

GMS5003
Fundamentals of Health Products Regulation

(4 modular credits)

This module 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.

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 Pre-Market Processes

GMS5004
Regulation of Pharmaceutical Manufacturing

(4 modular credits)

This module 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.

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GMS5108
Clinical Studies and Evaluation of Health Products

(4 modular credits)

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.

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 Post-Market Processes

GMS5114
Post-market for Medical Technologies

(4 modular credits)

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.

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GMS5115
Principles and Frameworks for Pharmacovigilance

(4 modular credits)

This module will explain the importance of manufacturing and quality control for pharmaceuticals.

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GMS5116
Post-Market Activities for Pharmaceuticals

(4 modular credits)

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.

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 Regulatory Trends

GMS5005
Regulation of Advanced Therapies

(4 modular credits)

This course aims to help students to understand and define advanced therapy products and differentiate them from chemical and biological entities.

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GMS5006
Regulation of Biotherapeutics and Biosimilars

(4 modular credits)

This module supports the Healthcare ITM by educating healthcare professionals like pharmacists and healthcare industry workers about biotherapeutics and biosimilars, which are innovative medicines that are treatment options for diseases like cancers, autoimmune disorders and diabetes that are increasingly affecting Singapore’s ageing population.

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GMS5007
Regulation of Generic Medicines

(4 modular credits)

This module supports the Healthcare ITM by educating healthcare professionals like pharmacists and healthcare industry workers about generic medicines, which are cheaper alternatives to brand name medicines on the market.

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GMS5106
Regulation of Digital Health Products

(4 modular credits)

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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GMS5107
In Vitro Diagnostics and Precision Medicine

(4 modular credits)

From this course, students should will be able to describe key regulatory requirements of IVDs through the total product life cycle and the conformity assessment methods by major authorities.

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