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).