[Email BannerFooter] CTP Programs 49

Tuesday, 22nd August 2023, 9am to 5pm

Delivered in person at Cicada Innovations and online 


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. 

What you'll learn:

  • How clinical trials, regulatory affairs, and quality management systems correspond to each other, what are the implications and do we need to consider them. 
  • Regulatory bodies, pathways, and timelines in Australia, the US, Canada, the UK, and Europe
  • Therapeutics & Pharmaceuticals Regulation:
    • Frameworks and classifications of medicines
    • Managing the planning process
    • Desired outcomes: 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 (including guidance, pre-submission options, etc).
    • Quality Management Systems (including design control process, post market surveillance requirements).
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One Day Seminars is part of the NSW Health Commercialisation Training Program. 

The Program aims to fast-track innovative ideas that will revolutionise the healthcare sector, improve patient outcomes, and provide economic opportunities for emerging medtech and biotech businesses in NSW. 

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