units

PSC3212

Faculty of Pharmacy and Pharmaceutical Sciences

18 September 2017 25 November 2024

print version

This unit entry is for students who completed this unit in 2016 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.

Monash University

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.

Faculty

Pharmacy and Pharmaceutical Sciences

Coordinator(s)

Dr Laurence Orlando

Offered

Parkville

  • Second semester 2016 (Day)

Notes

This unit was previously titled Product development.

Synopsis

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.

Outcomes

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

Assessment

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)

Dr Laurence Orlando

Prerequisites

PSC3231 Pharmaceutical product manufacture
PSC3041 Applied analytical methods
PSC3211 Industrial formulation

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

http://www.monash.edu/pharm/current/