6 points, SCA Band 2, 0.125 EFTSL
Undergraduate - Unit
Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.
- Second semester 2019 (On-campus)
This unit was previously titled Product development.
This unit will explore the regulatory aspects of the development and commercialisation 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:
- Explain the organisation of quality assurance in pharmaceutics and apply the relevant concepts to case studies
- 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
- Find and apply relevant pharmaceutical guidelines of worldwide regulatory bodies to case studies including clinical trials
- Understand the principles of intellectual property that apply to the development of pharmaceutical products
- Describe the submission and approval process for pharmaceutical products to stringent regulatory authorities
- Describe marketing regulations and controls related to commercialising pharmaceutical products
- Work in teams and apply critical thinking, communication and problem solving skills
60% in-semester assessment, 40% final assessment
Contact hours for on-campus students:
72 hours of workshops and consultation hours
See also Unit timetable information