Regulation of Medical Devices in Australia and New Zealand

Regulation of Medical Devices in Australia and New Zealand
This webinar will provide a high-level overview of the regulatory environment for medical devices in Australia, including clinical trial processes, expedited pathways and ongoing vigilance

When: This is a on-demand webinar available after the 2nd of July

Learning Objectives

  • Have an overview on the regulatory environment in Australia and New Zealand
  • Understand the basic process for registration in Australia and New Zealand
  • Understand the differences in regulatory processes
  • Learn about expedited pathways in the two regions

Target Audience

Regulatory affairs professionals with 2-5 years' experience who are interested in the regulatory processes and updates for Australia and New Zealand. Professionals who want to build on their general regulatory knowledge of major submissions and strategies for expedited pathways.


Jennifer Svec

After completing a PhD in Pharmacology at the University of Melbourne, Jennifer started working in the pharmaceutical industry in regulatory affairs in 1987. This gives her more than 33 years in regulatory affairs, and the industry, including work in big pharma (until 2004) and as a freelance consultant now for more than 15 years. most of her work has focused on prescription medicines (with a short period in generics) and mainly in submissions and strategies supporting clinical-based regulatory submissions (NCE/NBE submissions, clinical variations - extensions of indications, orphan drug designations and literature based submissions). More recently, Jennifer has been involved in the provisional approvals of both a covid-19 vaccine and a gene therapy, and has supported clients with expedited evaluation through the ACCESS consortium of health authorities. In addition to developing and delivering in-house training for clients, Jennifer has also acted as global regulatory lead for several early development products. As a result of working in the industry for over 35 years Jennifer has established professional relationships with staff at both TGA and Medsafe and maintains a wide network within the Australian industry, collaborating closely with other freelance consultants in areas including clinical research, toxicology evaluation and pharmacoeconomics, as well as regulatory affairs.

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