RFA regularly conducts training courses in our Glebe office meeting room. Courses are conducted confidentially for your company’s staff and are tailored to suit your needs, based on your product types and any specific regulatory problems you may be facing. Certificates are awarded to all attendees.

The cost per training session includes up to 4 attendees, all notes and course materials and includes morning tea, lunch, and afternoon tea (for full day courses). Two half day courses may be combined (on the same day) and will be charged at the full day rate. Additional attendees (more than 4 people) will incur an additional cost.
Please contact us for training costs. *Cost includes our preparation time but does not include any advice provided after the training session has ended.

Half day (4 hour) courses

1. Introduction to regulations for foods, medicines and cosmetics
Overview of State and Commonwealth legislation – the cosmetic/therapeutic interface – the food/therapeutic interface – relevant guidelines, orders and codes – overview of advertising regulations, overview of processes for new ingredient submissions

2. Cosmetic regulation
NICNAS applications, exemptions, and annual reporting – poisons schedules and other ingredient restrictions - AQIS quarantine issues - labelling and packaging requirements - cosmetic claims versus therapeutic claims – the cosmetic/therapeutic interface

3. Listed Medicines - advertising code
General principles: general, medium & high level claims - therapeutic claims evidence - specific indications e.g. weight loss & restricted representations - applications to advertising clearance bodies - comlaints: how to lodge and respond

4. Listed Medicines - product claims and indications
Formulation ingredient development in relation to claims, indications and evidence – reviewing marketing strategies - researching and sourcing traditional and scientific evidence - evaluating evidence and proposing acceptable claims and indications - compiling claims bibliography to TGA guidelines - how to respond to Section 31 notices

5. Listed Medicines - TGA eBS online applications
Overview of prerequisites such as product specifications, GMP preclearance - TGA online data functionality: how, where and what to access - entering data into eBS applications - compiling a listed medicine product dossier - Section 9d applications - responding to Section 31 and Section 14 requests - overview of processes for new ingredient submissions

6. Listed Medicines – the sponsor’s finished product specifications
Raw material specifications and relevant standards - acceptable formatting for formulation ingredients - overages, test methods & expiry/release limits - how to apply for exemptions from standards and Section 14 requests - overview of stability testing requirements – reading and interpreting certificates of analysis

7. Introduction to advertising regulations for marketing executives
Overview of legislation of foods, medicines, and cosmetics. Permitted claims and representations for different product categories. Advertising pre-clearances  and the roles of industry associations. How to work with your regulatory affairs team to achieve your marketing goals. How to submit and respond to complaints. 
 
8. Changes to code of GMP – sponsor’s responsibilities
Product quality reviews - ongoing stability programs - how to review your GMP contract agreements - reference and retention samples - complaints and product recalls – operating procedures

Full day course

9. Food Standards
Overview of the Australia/New Zealand regulatory systems - who is responsible for what? State versus Federal governments
Food Standards Code overview: How to find the relevant information such as labelling and general information
Specific product categories such as meal replacements, supplementary foods, formulated beverages, sports foods and foods for special medical purposes
Novel food applications
Recent changes in New Zealand

To contact us for further information click here.