EDUCATION ELEMENTS.
Take a shortcut to expertise with The Specialists.
Working in Complementary Medicines is a niche market and there are many aspects of ‘product development’ and ‘regs’ roles which just aren’t taught in a classroom (or a book). Industry giants and start ups alike often have team members who learnt their skills on the job, gathering their knowledge over the years, and have handed it down – good (and bad) habits included!
HPS’ Education Elements are a series of 9 modules, curated specifically for professionals engaged with product development.
It’s education for product development.
More power to you.
Who do we educate?
New starters in the industry
Professionals looking to refine or refresh their skills
Team members looking to advance their career
Time-poor brand marketers, contract manufacturers, raw material suppliers
How is the education delivered?
All sessions are live and individualised, enabling questions and discussions about challenges which your specific business is facing, maximising the practical usefulness of the session. Modules are priced per session, so as many (or as few) of your colleagues can participate as you like, at no extra charge.
What will you receive as a part of your education?
Training from the best minds in the business, along with detailed course notes and the ability to brag about your advanced training on your CV.
Regulatory Basics
4 hours – $985
- Who are the TGA, FSANZ and AICIS, and what do they do?
- Legislative overview.
- Product classifications.
- Where to look for information.
- Relationship management tips.
Evidence Development
4 hours – $985
- Why develop evidence?
- Legislative overview.
- Key principles of evidence development, including locating evidence, evidence classification and requirements, indication classification and requirements, presenting evidence, critical appraisals & justifications.
Labelling - Foods
2 hours – $495
- Mandatory inclusions.
- Nutrition Information Panel (NIP).
- Ingredient list requirements.
- Allergen declaration.
- Nutrition & Health Claims.
- Country of origin requirements.
Labelling - Medicines
2 hours – $495
- Design requirements.
- Mandatory inclusions.
- Ingredient declaration requirements.
- Allergen declaration.
- Indications & Claims.
- Country of origin requirements.
Specifications
2 hours – $495
- How to read and understand a specification.
- Raw material and Finished product specifications.
- Preparing specifications.
Formulation
4 hours – $985
- Formulation principles.
- Formulating to achieve desired claims.
- Choosing ingredients and packaging.
- Formulating to the regulatory category.
- Dosage form nuances- powders, capsules, tablets, liquids etc.
- Choosing your manufacturer.
- Understanding Cost of Goods (COGs ) and mark ups.
- Dosing and directions for use.
- Batch sizes.
Pharmacovigilance
2 hours – $495
- Key principles of pharmacovigilance – navigation of Australian and EU legislation and the interaction between them.
- Pharmacovigilance responsibilities of medicine sponsors.
- Reporting adverse events.
- TGA’s Pharmacovigilance Inspection Program.
- Safety assessments and how this impacts product development.
ARTG Listings
2 hours – $495
- What is eBS.
- How to navigate and find key information.
- Code tables.
- How to create a new listing.
- How to update an existing listing.
- Section 9D changes.
Personalised Education
Quoted
Need a little bit of everything?
Have a specific topic that you would like to brush up on?
We would be happy to curate a course, personalised to your needs.