Handbook

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.