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Modules

CALENDAR 2021-2022

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
No Change

GMS5107 In Vitro Diagnostics and Precision Medicine  New!

4 to 8 Oct 2021

Closed

  SGD5400*
(before GST)

SSG Approved
*Click here for
more details on
SSG funding

GMS5111 Pharmacovigilance: Principles and Frameworks

GMS5115 Principles and Frameworks for Pharmacovigilance 

11 to 15 Oct 2021

Closed

GMS5011 Fundamentals of Pharmaceutical Regulation

GMS5003 Fundamentals of Health Products Regulation

8 to 12 Nov 2021

Closed
5 to 9 Sep 2022  1 Jun to 24 Jun 2022

GMS5101 Clinical Trial Design and Data Analysis

GMS5108 Clinical Studies and Evaluation of Health Products

 17 to 21 Jan 2022

4 Oct to 29 Oct 2021

GMS5113 Post-market Surveillance and Enforcement

GMS5116 Post-Market Activities for Pharmaceuticals

21 to 25 Feb 2022

1 Nov to 26 Nov 2021

GMS5103 Regulation of Cell, Tissue and Gene Therapies

GMS5005 Regulation of Advanced Therapies

21 to 25 Mar 2022

 7 Dec 2021 to 4 Jan 2022

GMS5105 Generic Medicines 

 GMS5007 Regulation of Generic Medicines 

9 to 13 May 2022

7 Feb to 26 Feb 2022
GMS5104 Biotherapeutics and Biosimilars 

GMS5006 Regulation of Biotherapeutics and Biosimilars

 7 to 11 Nov 2022 1 Aug to 26 Aug 2022

No Change

 GMS5114 Post-market for Medical Technologies New! TBC TBC

No Change

 GMS5106 Regulation of Digital Health Products New! TBC TBC

GMS5012 Chemistry, Manufacturing and Controls
 GMS5004 Regulation of Pharmaceutical Manufacturing
 TBC TBC

    

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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