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GMS5003 Fundamentals of Health Products Regulation

 

15 Sep 2025, Monday - 19 Sep 2025, FridaySee Schedule below for times (GMT +8:00) Kuala Lumpur, Singapore

 

Duke-NUS Medical School, 8 College Rd, Singapore 169857, 169857

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Overview

The regulation of health products relies on standards, guidelines, and legal frameworks. Effective governance, ensuring timely access to safe, high-quality, and effective medicines for patients, depends on collaboration among stakeholders including the industry, regulatory authorities, healthcare professionals, and patients.

This foundational course explores the roles and contributions of various stakeholders, key functions, and guidelines that shape the regulatory landscape. It provides comprehensive insights into the end-to-end processes of pharmaceutical development, addressing regulatory requirements throughout the product lifecycle and contemporary regulatory approaches.

Course Description & Learning Outcomes

  • Explain the foundational basis of regulatory management and decision-making processes for pharmaceutical products, highlighting the key concepts involved in managing pharmaceuticals across their lifecycles

  • Understand the regulatory requirements for the different product development phases and learn about real-world regulatory decision-making through interactive, practical sessions

  • Learn about the key regulatory organisations driving innovation of regulatory processes and policies

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Schedule

Start Date: 15 Sep 2025, Monday
End Date: 19 Sep 2025, Friday

Monday - Friday, 830 AM - 530 PM

Location: Duke-NUS Medical School, 8 College Rd, Singapore 169857, 169857

Pricing

Course fees: SGD

Course Pricing

Skills Covered

PROFICIENCY LEVEL GUIDE
Beginner: Introduce the subject matter without the need to have any prerequisites.
Proficient: Requires learners to have prior knowledge of the subject.
Expert: Involves advanced and more complex understanding of the subject.

  • Product Development (Proficiency level: Beginner)
  • Product Management (Proficiency level: Beginner)
Technology:
Industries: