Note: This is an archived Handbook entry from 2016.
|Dates & Locations:|| |
This subject has the following teaching availabilities in 2016:Semester 2, Parkville - Taught on campus.
Timetable can be viewed here. For information about these dates, click here.
|Time Commitment:||Contact Hours: Eight 4-hour workshops, two workshops for each unit. |
Total Time Commitment:
|Recommended Background Knowledge:||None|
|Non Allowed Subjects:||None|
|Core Participation Requirements:||
For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Student Support and Engagement Policy, academic requirements for this subject are articulated in the Subject Overview, Learning Outcomes, Assessment and Generic Skills sections of this entry.
It is University policy to take all reasonable steps to minimise the impact of disability upon academic study, and reasonable adjustments will be made to enhance a student's participation in the University's programs. Students who feel their disability may impact on meeting the requirements of this subject are encouraged to discuss this matter with a Faculty Student Adviser and Student Equity and Disability Support: http://services.unimelb.edu.au/disability
CoordinatorDr Matthew Digby
The successful commercialisation and marketing of biotechnological products requires extensive documentation and rigorous evaluation by the relevant regulatory bodies.
This subject is comprised of four discreet units focusing on: the Australian Pesticides and Veterinary Medicines Authority (APVMA) Office of the Gene Technology Regulator (OGTR) Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ) and their international counterparts such as the USA Food and Drug Administration (FDA).
The regulatory requirements of devices, drugs and foods will be examined by a series of case study focused seminars and workshops, providing an understanding of the time frame, rigor, effort, and uncertainty encountered throughout the process of product registration.
Four 30 minute in-class tests, one for each unit, during semester: 40%
|Breadth Options:|| |
This subject is not available as a breadth subject.
|Fees Information:||Subject EFTSL, Level, Discipline & Census Date|
Students will develop:
|Links to further information:||http://graduate.science.unimelb.edu.au/|
Master of Biotechnology |
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