Undergraduate - UnitPSC3212 - Pharmaceutical Regulatory Framework

This unit entry is for students who completed this unit in 2014 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.

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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, or view unit timetables.

Level	Undergraduate
Faculty	Faculty of Pharmacy and Pharmaceutical Sciences
Offered	Parkville Second semester 2014 (Day)
Coordinator(s)	Dr Michelle McIntosh

Notes

Note: This unit was previously title Product development.

Synopsis

This unit will explore the regulatory aspects of the development 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:

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

Assessment

60% in-semester assessment, 40% final assessment

Chief examiner(s)

Dr Michelle McIntosh

Workload requirements

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

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/