Faculty of Pharmacy and Pharmaceutical Sciences

Monash University

Undergraduate - Unit

This unit entry is for students who completed this unit in 2015 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

print version

6 points, SCA Band 2, 0.125 EFTSL

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.

FacultyFaculty of Pharmacy and Pharmaceutical Sciences
OfferedParkville Second semester 2015 (Day)
Coordinator(s)Dr Michelle McIntosh


This unit was previously titled Product development.


This unit will explore the regulatory aspects of the development of pharmaceutical products, including quality, intellectual property, market authorisation, dossier submission processes and marketing.


At the end of this unit students will be able to:

  1. Explain the organisation of quality assurance in pharmaceutics and apply the relevant concepts to case studies
  2. Describe the categories of good manufacturing practice (GMP) elements, interpret and apply relevant principles of GMP in selected areas of pharmaceutical product development in the context of total quality
  3. Find and apply relevant pharmaceutical guidelines of worldwide regulatory bodies to case studies including clinical trials
  4. Understand the principles of intellectual property that apply to the development of pharmaceutical products
  5. Describe the submission and approval process for pharmaceutical products to stringent regulatory authorities
  6. Describe marketing regulations and controls related to commercialising pharmaceutical products
  7. Work in teams and apply critical thinking, communication and problem solving skills


60% in-semester assessment, 40% final assessment

Workload requirements

Contact hours for on-campus students:
72 hours of workshops and consultation hours

See also Unit timetable information

Chief examiner(s)


PSC3231 Pharmaceutical product manufacture
PSC3041 Applied analytical methods
PSC3211 Industrial formulation

Additional information on this unit is available from the faculty at: