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School of Medical Sciences Law Masterclass 2018: Therapeutic Goods Regulation in Australia The Challenge of Change

This Masterclass is addressed to non-legal executives and interested persons to explain the
policy drivers, legal framework and related practices concerning the registration and listing of
therapeutic goods under the Therapeutic Goods Act 1989.
Sessions will address the development of policy, the resultant law and related practice
relating to therapeutic goods in every day English terms with relevant examples. The
Masterclass will end with an in-depth discussion of contemporary issues impacting the
therapeutics industry in Australia.

Learning Outcomes:

By the end of this Masterclass you will be able to:

  • Understand the history and development of therapeutics goods regulation in Australia
  • Explain the legal framework supporting the regulation of therapeutic goods in Australia
  • Assess the policy environment and understand the implications of recent amendments to the regulation of therapeutic goods in Australia
  • Evaluate the future regulatory environment for therapeutic goods in Australia


  • Dr. Orin Chisholm – Program Director and Senior Lecturer in Pharmaceutical Medicine, School of Medical Sciences, UNSW
  • Allan Anforth – Lecturer in Therapeutic Goods Law, UNSW, Master of Pharmaceutical Medicine program; Adjunct Professor of Law, University of Canberra, Barrister Canberra Chambers, Canberra
  • Doug Kentwell – Principal Consultant, Capital K Consultants
  • Jenny Francis – Principal Legal and Policy Advisor, Health Products Regulation Group
  • Elizabeth de Somer – CEO, Medicines Australia
Event Date: 
Friday, 23 November 2018 - 9:00am
UNSW CBD Campus, Level 6, 1 O'Connell Street, Sydney, NSW 2000
Booking deadline: