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
Feedback
shaista_pandit1314.
Informative, precise and properly guided
The course was very informative and very well presented. All the questions that I had before starting the course, were very well captured throughout the course and not many questions were left unanswered considering it was an e-learning course. This course has certainly assisted with providing a lot of clarification on many things and Abby has dug in deep to explain the process. The materials provided for the course is also great.