Session objectives:
- Share high-level overview of Facilitated Product Introduction & TGA’s Regulatory Strengthening Program
- Provide platform for greater understanding of ACCESS Consortium (how it works, future plans, industry experience, etc.)
Michael Wiseman has over 27 years’ experience working in medicines regulation in both Australia and Canada. Michael has worked across several regulatory areas, including TGA’s laboratories, complementary and over-the-counter medicines, prescription medicines, and corporate support areas.
As a senior executive, Michael has led TGA’s Laboratories Branch and the Scientific Evaluation Branch, before taking on his current role as Assistant Secretary, International Regulatory Branch (IRB). The IRB was formed in October 2021 in response to the significant increase in international collaboration, work-sharing and regulatory reliance activities brought about by the global COVID-19 pandemic.
The IRB also manages and delivers the Indo Pacific Regulatory Strengthening Program (RSP) – a technical assistance program aimed at supporting and advancing regulatory system strengthening in the Indo-Pacific region. Michael has led the RSP since its inception in 2018.
The IRB is also responsible for managing and administering the regulatory pathways for access to unapproved products, through the Special Access and Authorised Prescriber pathways. These pathways are also used for access to medicinal cannabis.
Session objectives:
