Food and Drug Law

Subject LAWS70339 (2010)

Note: This is an archived Handbook entry from 2010.

Credit Points: 12.50
Level: 7 (Graduate/Postgraduate)
Dates & Locations:

This subject has the following teaching availabilities in 2010:

May, 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: The total class time is between 24 and 26 hours.
Total Time Commitment: Visit the Melbourne Law Masters website for more information about this subject.
Prerequisites: Visit the Melbourne Law Masters website for more information about this subject.
Corequisites: Visit the Melbourne Law Masters website for more information about this subject.
Recommended Background Knowledge: Visit the Melbourne Law Masters website for more information about this subject.
Non Allowed Subjects: Visit the Melbourne Law Masters website for more information about this subject.
Core Participation Requirements: Visit the Melbourne Law Masters website for more information about this subject.

Contact

For the most up-to-date information about this subject, contact the Melbourne Law Masters Office by email at law-masters@unimelb.edu.au or phone 8344 6190 or alternatively visit the subject website: www.masters.law.unimelb.edu.au
Subject Overview:

This subject will provide students with a solid understanding of the regulation of food, drugs and medical devices. The regulatory regime for each of these products, especially drugs, is complex. The subject will focus primarily on the regulation of these products in the United States, which has well-developed approaches in each area and has also (especially with respect to drugs) provided a model for other governments' regulation of these products. The subject will also focus on European, Australian, and international approaches.
Principal topics will include:

  • Regulation of food labelling, genetically modified foods and food contaminants
  • Regulation of the safety and effectiveness of prescription drugs, including the regulation of clinical testing of new drugs
  • Regulation of the safety and effectiveness of generic and over-the-counter drugs
  • Regulation of medical devices and frontier medical technologies.
Objectives:

A student who has successfully completed this subject should:

  • Have a solid understanding of the regulation of food, drugs and medical devices in the United States
  • Have an understanding of European and Australian approaches to food, drug and medical device regulation
  • Understand the major national and international institutions that participate in the regulation of food, drugs and medical devices
  • Appreciate the policy challenges associated with each area of regulation
  • Appreciate the tradeoffs between safety and innovation that are especially prevalent in the area of medical product regulation.
Assessment:

Take-home examination (100%)
(2-5 July)

Prescribed Texts: Visit the subject website for more information
Breadth Options:

This subject is not available as a breadth subject.

Fees Information: Subject EFTSL, Level, Discipline & Census Date
Generic Skills: Visit the Melbourne Law Masters website for more information about this subject.
Links to further information: http://www.masters.law.unimelb.edu.au/

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