The one-day seminars series covers four key topics which are key during the commercialisation and development of health innovations - intellectual property, regulation and regulatory affairs, clinical trials, and navigating the healthcare system.

Delivered in person and online

Regulation & Regulatory Affairs Seminar

This seminar is for anyone who wants to develop a high-level understanding of the regulatory landscape and pathways for NSW-based innovations who have a global view. During this seminar, you’ll hear from experts about the key details you need to understand about regulatory affairs in Australia, the United States, Canada, the United Kingdom, and Europe.

- Correspondence and implications of clinical trials, regulatory affairs, and quality management systems
- Regulatory bodies, pathways, and timelines in Australia, the US, Canada, the UK, and Europe.
- Therapeutics & Pharmaceuticals Regulation including frameworks and classifications of medicines, managing the planning process, developing with the outcome in mind, product development, sale/supply, and post-marketing.
- Medical Device, Diagnostics, and Software as a Medical Device Regulation in Australia: Regulations, definitions, and classification, Regulatory submissions, and Quality Management Systems

This seminar is free and open to NSW residents.
Non-NSW residents may attend online or in person for a fee.
(please see at checkout)

Regulation & Regulatory Affairs Seminar

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