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,
Sem 1 2019,
Sem 1 2020,
Sem 1 2021,
Sem 1 2022,
Sem 1 2023,
Sem 1 2024

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

Enforced Pre-Requisite Courses

Successful completion of:

Note: it is a condition of enrolment at RMIT that you accept responsibility for ensuring that you have completed the prerequisite/s and agree to concurrently enrol in co-requisite courses before enrolling in a course.

For information go to RMIT Course Requisites webpage.

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

You will be actively engaged in a range of learning activities such as lectorials, tutorials, practicals, laboratories, seminars, project work, class discussion, individual and group activities. Delivery may be face to face, online or a mix of both.

You are encouraged to be proactive and self-directed in your learning, asking questions of your lecturer and/or peers and seeking out information as required, especially from the numerous sources available through the RMIT library, and through links and material specific to this course that is available through myRMIT Studies Course.

Overview of Learning Resources

RMIT will provide you with resources and tools for learning in this course through myRMIT Studies Course.

There are services available to support your learning through the University Library. The Library provides guides on academic referencing and subject specialist help as well as a range of study support services. For further information, please visit the Library page on the RMIT University website and the myRMIT student portal.

Overview of Assessment

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

If you have a long-term medical condition and/or disability it may be possible to negotiate to vary aspects of the learning or assessment methods. You can contact the program coordinator or Equitable Learning Services if you would like to find out more.