We offer training courses for:
- Anyone new to regulatory affairs or for those wanting to update their skills and knowledge
- Current marketing and technical staff
- Those of you transitioning into this area or wanting to work in Regulatory Affairs
- On-line learning (Zoom or Skype)
- Face-to-face (once covid-19 pandemic ceases)
- Cost effective
- Time effective (1 – 2 hour duration)
- Grow your skills quickly
01. Introduction to Regulatory Affairs in Australia
Practical, introductory session which will provide you with a solid grounding of the regulatory requirements in Australia for foods, cosmetics and complementary medicines.
02. Evidence Packages
In this 2 hour session we guide you on how to prepare an evidence package to TGA requirements. The format, content, troubleshooting issues and how to research.
The requirements of TGO 92 (the labelling order), explained. Learn how to check your label for compliance. Session includes a label template and example.
04. Product Advertising
The Therapeutic Goods Advertising Code – an overview of the requirements of the advertising code so you can ensure your ads comply.
05. Finished product specifications
06. Stability testing
07. Product quality reviews
08. GMP agreements
09. Pharmacovigilance obligations
21. Introduction to cosmetic regulations in Australia
Gives you the knowledge of cosmetic regulatory requirements.
Learn how to check your cosmetic labels for compliance against relevant cosmetic labelling legislation.
Learn how to assess food ingredients, which standard to apply.
Learn how to label food products to legislative requirements. Includes template and guidance on Nutrition Information Panel requirements.
Ellie Kim BMedSc, BHSc (Chinese Med), MHerbMed (Hons)
Regulatory Affairs Manager
Kate Durey BA (Hons), BHSc (Naturopathy), Dip Western HerbMed, Dip Nutrition
Samantha King BAppSc (Food and Nutrition), MPH (Nutrition)
Senior Regulatory Affairs Associate
Quentin R Blades MMedSc (Drug Development)