MPS5304 · Regulatory science and monitoring medicine use

Overview

This unit guides you through the paradigm in which approved medicines are monitored and regulated in their wider clinical use. In the unit, you will build a foundation understanding of pharmacoepidemiology, pharmacoeconomics, and the safe use of medicines through the lens of evidence-based practice. You will explore the frameworks used to evaluate medicine use and cost-effectiveness to inform policy and funding decisions, as well as drive clinical decision making. Upon completing this unit, you will have a comprehensive view of the issues surrounding the effective use of medicines in the broader population, and how to address these global issues from a practical perspective.

Offerings

Assessment

The Handbook does not list a final examination among the assessment items. That is not a guarantee there is none.

Assessment in this unit includes competency hurdle assessment task(s). You have one attempt, plus an additional assessment capped at 50% of the available marks for the task, to demonstrate your competency in the competency hurdle assessment task(s). If you fail to meet the hurdle requirement, you will receive a fail grade for the unit regardless of the total marks you achieve.

Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.

Requisites

The Handbook lists no prerequisite, corequisite or prohibition for this unit.

Learning outcomes

1. Critically appraise and apply research evidence as the basis for clinical and regulatory decision making
2. Critically examine and report on the pharmacoepidemiology of medicines in a contemporary context
3. Examine and critically apply the principles of health economics and pharmacoeconomics in the drug evaluation lifecycle
4. Critically evaluate different sources of evidence including clinical practice guidelines, systematic reviews and meta-analyses regarding the benefits and risks of medicine treatment
5. Synthesise and critically examine the complex interplay of comparative effectiveness with the economic, legal, ethical, social and sustainability aspects in drug development and use
6. Demonstrate effective oral and written communication skills to communicate findings regarding regulatory science and the monitoring of medicine use in the wider population.

Workload

• 24 hours of preparation for classes • Twelve 1-hour applied classes • Twelve 2-hour workshops • 5 hours of assessments • 54 hours of independent work • 25 hours of group work

Student experience, not official rules. Nothing here changes what the Handbook says.