Course Title: Clinical Development of New Medicines

Part A: Course Overview

Course Title: Clinical Development of New Medicines

Credit Points: 12.00


Course Code




Learning Mode

Teaching Period(s)


Bundoora Campus


160H Medical Sciences


Sem 1 2014,
Sem 1 2015


Bundoora Campus


173H School of Health and Biomed


Sem 1 2017

Course Coordinator: Dr Celine Valery

Course Coordinator Phone: +61 3 9925 7482

Course Coordinator Email:

Course Coordinator Location: 201.02.038

Course Coordinator Availability: by appointment

Pre-requisite Courses and Assumed Knowledge and Capabilities

System Enforced Pre-requisites (Enforced by SAMS)





Course Description

This course develops the knowledge of the clinical development of new medicines and applied understanding necessary for a pharmacist in a drug development career setting. The course has been developed around teaching the competencies within essential domains.  These domains are: biologic medicines and biosimilars, new drug targets and pharmacogenomics, clinical trial design, ethics & misconduct, regulation of supply of therapeutic goods, pharmacovigilance, health economics, marketing and medical information.

Objectives/Learning Outcomes/Capability Development


This course contributes to capability development in the following Domains of the National Competency Standards Framework for Pharmacists in Australia:

  • Domain 1 - Professional and Ethical Practice
  • Domain 2 - Communication, collaboration and self-management
  • Domain 4 - Review and supply prescribed medicines
  • Domain 5 - Prepare pharmaceutical products
  • Domain 6 - Deliver primary and preventive health care


Upon completion of this course, you should be able to:

  1. examine clinical evaluation of new and existing drugs and medicines, and post-marketing surveillance.
  2. evaluate prospects for new approaches in therapeutics.
  3. apply professional standards in relation to schedules of medicines and controlled substances; PBS (Aust) and Pharmacy scheduling (NZ); consumer protection, including product liability and unapproved medicines.
  4. evaluate the influence of manufacture and distribution on product quality with respect to biological safety, bioavailability (including bioequivalence), dosage uniformity and stability
  5. relate purpose, design and evaluation of packaging and labelling
  6. leverage the role of quality assurance of pharmaceutical products and processes, including Good Laboratory Practice and Good Manufacturing Practice.
  7. levarage environmental control in manufacturing facilities and in the supply chain, degradation of medicines; evaluation and control of biological, chemical and physical degradation
  8. apply the duty of care to the patient and the wider public:  concepts, scope and application to professional ethics

Overview of Learning Activities


A number of different learning activities will be used to enable you to develop the required knowledge and capabilities. These include:

  • Didactic lectures;
  • Problem based workshops, tutorials and lectorials.


Face-to-face learning: four (4) hours per week for one semester comprising lectures and tutorials.

Independent study: two (2) hours per week for one semester, including analysing articles, writing essays, working on project, revising lectures and tutorials.

Overview of Learning Resources

There are a number of different learning resources to support the teaching and learning activities within this course. These include lecture notes, tutorial workbook, digitised readings and e-books. You will be provided links to the relevant Australian Codes and Guidelines.

Overview of Assessment


☒This course has no hurdle requirements.

☐ All hurdle requirements for this course are indicated clearly in the assessment regime that follows, against the relevant assessment task(s) and all have been approved by the College Deputy Pro Vice-Chancellor (Leaning & Teaching).

Assessment components may include:

  • Conducting a project on the development of a new medicine            (worth 20% of total mark). This assessment covers CLOs 1,3,4,7,6.
  • Weekly tests on lecture/workshop material (worth 20% of total mark). These assessments cover CLOs 1-8
  • A mid semester summative written examination (worth 30% of total mark). This assessment covers CLOs 2-4
  • A final summative written examination (worth 30% of total mark). This assessment covers CLOs 1-8.