Description
Part 1 The TGA regulatory framework
- Overview
- ‘Permissible’ ingredient
- Application categories
- Comparable Overseas Body
- Mandatory requirements
Part 2 Quality
- Default standard v compositional guideline
- Batch analysis
- Stability
Part 3 Safety
- Systematic literature review
- ‘Safety’ studies
- Market data
Part 4 Important considerations
- TGA approval, including an exercise
- Market exclusivity and ‘concurrent’ submissions
- Pre-submission advice
- Feasibility
Part 5 Useful links
Part 6 Resources
Duration: 1.5 hrs
*10% GST is added if we are billing an Australian company
Extra attendees – $50 per person
