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Modules

CALENDAR (2020 - 2021)*

*Tentative dates of all the modules workshop. Dates will be confirmed at the beginning of each semester

  2020-2021 GC calendar for website_18 Mar      

  
CLICK ON THE COURSES BELOW TO REGISTER

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GMS5011
Fundamentals of Pharmaceutical Regulation

This fundamental module provides the understanding of the contribution of the various stakeholders, functions and guidelines that shape the regulatory environment and impact the healthcare management scene.

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GMS5104
Biotherapeutics and Biosimilars

This module provides the background to the rise of these biologicals in healthcare, and the defining differences from traditional pharmaceuticals and generics.

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GMS5012
Chemistry, Manufacturing and Controls

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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GMS5111
Pharmacovigilance: Principles and Frameworks

Within this module, the principles, frameworks and processes for pharmacovigilance will be introduced. Various platforms and partnerships among regulatory stakeholders for ensuring adequate and quality pharmacovigilance data will be also covered.

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clinical trials

GMS5101
Clinical Trial Design and Data Analysis

This module provides the understanding for the unique requirements of clinical trials and clinical data meant to support regulatory evaluation and approvals.

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GMS5113
Post-market Surveillance and Enforcement

Key activities and roles essential for effective post-market control, will be introduced, including managing failures of conformance and compliance. Topics covered will include collaborations and networks for optimising post-market communications, and handling of substandard and falsified pharmaceuticals.

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cell therapies

GMS5103
Regulation of Cell, Tissue and Gene Therapies

The module will interest students who are keen in global trending regulatory approaches and strengthening the skillsets to accommodate new innovation.

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GMS5105
Generic Medicines

This module aims to equip students with skills to assess the therapeutic equivalence of a generic medicinal product relative to a comparator, specifically with respect to bioavailability (BA) and bioequivalence (BE).

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