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PC5519 - Pharmaceutical Regulation and Quality

Credit points: 3
Year: 2019
Student Contribution Band: Band 2
Administered by: College of Medicine & Dentistry

The delivery of quality medicines to customers is integral to achieving therapeutic outcomes for patients ensuring that the pharmaceuticals are not only of an appropriate quality but also efficacious and safe. Pharmaceutical regulation is key to achieving these therapeutic outcomes. The challenge is to achieve consistency in pharmaceutical regulation and quality worldwide, where although regulation is stringent in the developed world, in developing countries, the poorest patients are constantly exposed to medicines of inferior quality used to treat life-threatening diseases. This subject will introduce the student to indicators for the quality assessment of medicines, the regulatory frameworks in the developed world and the challenges to regulation in developing countries. In addition the concepts of counterfeit and substandard medicines will be described in addition to the design of appropriate methods to detect these medicines which are lacking in quality. It is important that this will provide guidance to the students to play a role in improving the quality of medicines for their patients as the gatekeepers in the public health area.

Learning Outcomes

  • demonstrate an understanding of how the quality of medicines is measured and a general view on the quality determinants of medicines;
  • demonstrate an ability to critically analyse, review and evaluate regulatory initiatives worldwide;
  • demonstrate an ability to conceptualise and evaluate a range of solutions to both identify and address issues related to the quality of medicines worldwide;
  • demonstrate an ability to critically analyse and review a situation in a particular country (type of country) in order to develop strategies for the establishment of an appropriate regulatory framework.

Availabilities

External, Study Period 1
Census Date 28-Mar-2019
Coordinator: Professor Beverley Glass
Lecturer: Mrs Robin Warren.
Method of Delivery: WWW - LearnJCUandPrinted materials
Assessment: assignment (40%); project (60%).

Note: Minor variations might occur due to the continuous Subject quality improvement process, and in case of minor variation(s) in assessment details, the Subject Outline represents the latest official information.