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,
Sem 1 2018

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 Program Learning Objectives:

     PLO2. Research, critically evaluate and apply evidence in professional practice

      PLO3. Demonstrate team and leadership skills to optimise practice

      PLO7. Apply pharmaceutical, medication and health knowledge and skills to improve patient and population health

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 registration, advertising, and pharmacovigilance. 
  4. evaluate the influence of manufacture and distribution on product quality with respect to biological safety, bioavailability (including bioequivalence), dosage uniformity and stability
  5. consolidate team working and leadership skills to optimise practice

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.

Assessment Tasks

Assessment Task 1: Conducting a team project on the development of a new medicine

Weighting 30%

This assessment task supports CLOs 1, 2, 3, 4 & 5

Assessment Task 2: Online tests on lecture/workshop material

Weighting 10%

These assessments task supports CLOs 1, 2, 3 & 4

Assessment Task 3: A mid semester summative written examination

Weighting 30%

This assessment task supports CLOs 1, 2, 3 & 4

Assessment Task 4: A final summative written examination

Weighting 30%

This assessment task supports CLOs 1, 2, 3 & 4