PC5519 - Pharmaceutical Regulation and Quality
|Student Contribution Band:
||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.
- 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
- 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.
Study Period 1
|Census Date 28-Mar-2019
||Professor Beverley Glass
||Mrs Robin Warren.
|Method of Delivery:
||WWW - LearnJCUandPrinted materials
||assignment (40%); project (60%).
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