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Advanced Regulatory Affairs - PHAR9113
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Faculty: Faculty of Medicine
 
 
School:  School of Medical Sciences
 
 
Course Outline: http://drugdev.med.unsw.edu.au/
 
 
Campus: Kensington Campus
 
 
Career: Postgraduate
 
 
Units of Credit: 6
 
 
EFTSL: 0.12500 (more info)
 
 
Indicative Contact Hours per Week: 0
 
 
CSS Contribution Charge:Band 1 (more info)
 
 
Tuition Fee:See Tuition Fee Schedule
 
 
Further Information: See Class Timetable
 
 

Description

PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9113.

This course extends the core course PHAR9104, by providing a comprehensive examination of the role of the international regulatory agencies such as those of the European Union and the United States and their influence on the Australian regulatory processes examined.  The major emphasis of the course will be on case studies and critical appraisal. Students review registration dossiers, write evaluation reports and prepare responses for pre-committee (ACPM) meetings.. The focus is on providing students with working examples to give experience in preparing regulatory submissions, finding appropriate guidelines, and ensuring an understanding of the regulatory processes involved. Scenario based problems are used to provide examples of decision making both within the regulatory agencies, and those required by sponsors.

Note: This course is elective for Programme 9060

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© The University of New South Wales (CRICOS Provider No.: 00098G), 2004-2011. The information contained in this Handbook is indicative only. While every effort is made to keep this information up-to-date, the University reserves the right to discontinue or vary arrangements, programs and courses at any time without notice and at its discretion. While the University will try to avoid or minimise any inconvenience, changes may also be made to programs, courses and staff after enrolment. The University may also set limits on the number of students in a course.