Description
Written and presented by product development specialist Abbie Harris, co-founder at Regulatory Training Direct and Principal Consultant at Natural Product Centre. This course is for anyone wanting to learn how to prepare evidence packages to substantiate therapeutic indications and claims on Australian listed complementary medicines. Critical issues covered include the Australian regulations for making therapeutic claims, how to find evidence and evaluate evidence, as well as how to compile an evidence package.
Part 1 – Foundations
- Regulatory Framework
- Overarching principles
- Types of indications
- Types of evidence
- Minimum evidence requirements
- TGA evidence package requirements
Part 2 – Researching
- How to find evidence – literature searches
- How to find evidence – sources of evidence
- How to utilise electronic databases
- How to assess evidence – relevance
- How to assess evidence – quality
- How to assess evidence – balance
Part 3 – Compiling an evidence package
- Overview
- TGA checklists
- General requirements (cover page)
- Evidence search strategy
- Evidence filters
- Evidence summaries
- Critical appraisals
- Justifications
This course includes extensive resources and templates. Attendees receive a list of evidence sources and a user-friendly evidence package template. The course also includes hints, tips, examples and case studies.
*10% GST is added if we are billing an Australian company
Course sample
