Drug Info., Regulation and Legal Issues

Subject PHRM90008 (2010)

Note: This is an archived Handbook entry from 2010.

Credit Points: 20
Level: 9 (Graduate/Postgraduate)
Dates & Locations:

This subject has the following teaching availabilities in 2010:

Semester 2, Parkville - Taught online/distance.
Pre-teaching Period Start not applicable
Teaching Period not applicable
Assessment Period End not applicable
Last date to Self-Enrol not applicable
Census Date not applicable
Last date to Withdraw without fail not applicable

Semester 2, Parkville - Taught on campus.
Pre-teaching Period Start not applicable
Teaching Period not applicable
Assessment Period End not applicable
Last date to Self-Enrol not applicable
Census Date not applicable
Last date to Withdraw without fail not applicable


Timetable can be viewed here. For information about these dates, click here.
Time Commitment: Contact Hours: 30 contact hours (3 hours per week)
Total Time Commitment: Not available
Prerequisites: Nil
Corequisites: .
Recommended Background Knowledge: .
Non Allowed Subjects: .
Core Participation Requirements: For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this subject are articulated in the Subject Description, Subject Objectives, Generic Skills and Assessment Requirements of this entry. The University is dedicated to provide support to those with special requirements. Further details on the disability support scheme can be found at the Disability Liaison Unit website : http://www.services.unimelb.edu.au/disability/ .

Contact

Professor Albert Frauman, albertf@unimelb.edu.au
Subject Overview: This subject aims to provide a background to practical and policy issues in drug regulation in Australia, Europe, USA and Asia, and in particular the regulatory process in Australia at government and industry level. In addition, students should gain an understanding of the drug evaluation process of primary pharmaceutical material in order to facilitate understanding of government regulatory requirements. Consumer issues, pharmacoeconomics and post-marketing surveillance in addition to epidemiology and clinical trial design, are also covered.

Objectives: .
Assessment:
  • 50% : Multiple Choice Questionnaire;
  • 50% : Short Essay Examination (Max: 2,500 words).

Prescribed Texts: .
Breadth Options:

This subject is not available as a breadth subject.
Fees Information: Subject EFTSL, Level, Discipline & Census Date
Related Course(s): Graduate Diploma in Drug Evaluation and Pharmaceutical Sciences

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