Advanced Regulatory Affairs - PHAR9113
Faculty: Faculty of Medicine
School: School of Medical Sciences
Course Outline: http://drugdev.med.unsw.edu.au/
Campus: Sydney
Career: Postgraduate
Units of Credit: 6
EFTSL: 0.12500 (more info)
Indicative Contact Hours per Week: 0
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 - 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
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
Study Levels
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