Adaptive regulation for digital health technologies - A pathway for industry

March 24, 2021
Mar 24, 2021 01:00 PM in Canberra, Melbourne, Sydney

Digital health technologies (DHTs) have the potential to disrupt both the medical technology, biotechnology and pharmaceutical sector and the broader delivery of healthcare, creating challenges for the effective and timely regulation of new therapeutic goods.

Join us for this seminar to embark on the journey that a digital medical technology company takes to commercialise their product. It’s a world which is rapidly evolving for digital medical devices and also highly regulated. Hear about Australian companies who are working within the regulatory framework to develop their innovations.

The session will also focus on how Australia’s regulator, the Therapeutic Goods Administration (TGA), works to ensure its regulations are fit for purpose to adapt to the rapid evolution of digital health technologies whilst protecting patients and consumers.

MTPConnect recently released a new report 'Adaptive Regulation for Digital Health: Enhancing Australia’s Regulation System' that examines how digital health industry stakeholders are engaging with the Australian therapeutic goods regulatory framework, and focused on research into DHTs regulated as medical devices – including software as a medical device (SaMD) and physical medical devices with associated software.

This session, hosted by MTPConnect’s Director Stakeholder Engagement QLD, Dr Andrew Bowskill, and moderated by Dr Lisette Pregelj from the University of Queensland, who co-authored MTConnect’s report, includes experts and companies involved in the report:

• Cardihab CEO Helen Souris
• ANDHealth CEO & Founder Bronwyn Le Grice

A Q&A session will be held at the end of the session.

AUDIENCE: Innovators/researchers developing digital medical technology and digital devices, Australian start-ups, SMEs and larger companies, regulatory teams, research institutes, university professional staff.

DURATION: 1 hour


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