Course Title: Clinical Development of New Medicines

Part A: Course Overview

Course Title: Clinical Development of New Medicines

Credit Points: 12.00

Important Information:

To participate in any RMIT course in-person activities or assessment, you will need to comply with RMIT vaccination requirements which are applicable during the duration of the course. This RMIT requirement includes being vaccinated against COVID-19 or holding a valid medical exemption. 

Please read this RMIT Enrolment Procedure as it has important information regarding COVID vaccination and your study at RMIT:

Please read the Student website for additional requirements of in-person attendance: 

Please check your Canvas course shell closer to when the course starts to see if this course requires mandatory in-person attendance. The delivery method of the course might have to change quickly in response to changes in the local state/national directive regarding in-person course attendance. 


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,
Sem 1 2019,
Sem 1 2020,
Sem 1 2021,
Sem 1 2022

Course Coordinator: Dr Celine Valery

Course Coordinator Phone: +61 3 9925 7482

Course Coordinator Email:

Course Coordinator Location: 201.08.038

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:

  • PLO 2. Research, critically evaluate and apply evidence in professional practice
  • PLO 3. Demonstrate team and leadership skills to optimise practice
  • PLO 7. Apply pharmaceutical, medication and health knowledge and skills to improve patient and population health

Upon successful 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 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, project templates and 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 35%

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

Assessment Task 2: Online quizzes on lecture/workshop material

Weighting 10%

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

Assessment Task 3: In-semester assessments

Weighting 40%

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

Assessment Task 4: A written reflection assignment

Weighting 15%

This assessment task supports CLO 5