International Regulatory Affairs - PHAR9113
Faculty: Faculty of Medicine
School: School of Medical Sciences
Course Outline: http://pharmmed.med.unsw.edu.au/
Campus: Sydney
Career: Postgraduate
Units of Credit: 6
EFTSL: 0.12500 (more info)
Indicative Contact Hours per Week: 10
CSS Contribution Charge: 1 (more info)
Tuition Fee: See Tuition Fee Schedule
Further Information: See Class Timetable
View course information for previous years.
Description
PLEASE NOTE: This course has had a change of code and title - up to and including 2009, the course code was PHPH9113. Up to and including 2016, the course title was Advanced Regulatory Affairs.
The course is designed to provide students with the skills in choosing and applying strategies for an application for a Therapeutic product to be registered and approved for marketing within Australia. Students will also examine approaches taken in the European Union and the USA and will be introduced to some regional jurisdictions such as Japan, China and south-east Asian countries. The course also covers the regulation of genetically-modified organisms (GMOs) in Australia and elsewhere. Students will learn about the emerging area of regulatory intelligence. Finally they will investigate the role of regulatory strategy in supporting the commercial needs of the company.
Note: This course is one of two options for the compulsory Regulatory Affairs component for programmes 5371 and 9370.
The course is designed to provide students with the skills in choosing and applying strategies for an application for a Therapeutic product to be registered and approved for marketing within Australia. Students will also examine approaches taken in the European Union and the USA and will be introduced to some regional jurisdictions such as Japan, China and south-east Asian countries. The course also covers the regulation of genetically-modified organisms (GMOs) in Australia and elsewhere. Students will learn about the emerging area of regulatory intelligence. Finally they will investigate the role of regulatory strategy in supporting the commercial needs of the company.
Note: This course is one of two options for the compulsory Regulatory Affairs component for programmes 5371 and 9370.
Study Levels
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