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Graduate Certificate in Regulatory Science

University of Wollongong

Type of institution: University/Higher Education Institution
Level: Postgraduate
CRICOS: 00102E

The Graduate Certificate has been developed with industry in mind, to provide real-life case studies from authentic experiences, providing students with the best educational outcomes. Students will learn about the framework in which regulatory affairs are conducted by examination of the origins and current methodologies implemented by host regulatory authorities. It also examines the essential integration of quality management principles for effective execution of regulatory affairs. Students will develop knowledge and skills in the requirements for regulatory oversight throughout the product placement, post-market vigilance and monitoring phases of the Product Life Cycle. Students will develop strategies to balance business objectives and compliance with regulatory requirements through the identification of risks and unknowns with marketing strategies.

Designed for

Health care professionals

Structure

2 x 12 credit point subjects offered by flexible delivery

Subjects

  • Fundamentals of Regulatory Science
  • Regulatory Science Interfacing, Vigilance and Monitoring

Standard entry requirements

Tertiary qualification or equivalent experience in the area of regulatory affairs.

Study pathways

Applicants may have experience in; quality assurance, medical products sales and marketing, medical products importation, government policy, medical products distribution, healthcare, government procurement, private health insurance.

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