This is a free workshop aimed at beginners who are unfamiliar with or new to therapeutic goods regulation. This may include:

• small to medium enterprises (SMEs)
• start-ups
• researchers

If you are making therapeutic claims about a product or have a product that is likely to be considered a therapeutic good, this workshop will help you understand your responsibilities at different stages of the regulation process.

PART I: Basics of regulation - an overview of therapeutic goods regulation, the role of TGA and sponsor responsibilities when supplying therapeutic goods in Australia.

PART II: Case studies - general principles of market authorisation, manufacturing, advertising and post-market monitoring as they relate to therapeutic goods.

PART III: Product focus session (subject to demand) - various sessions focusing on specific product types.

PART IV: Q&A with TGA staff - opportunity to ask general questions.

"It was a very well planned and executed event. I thought the presentations 'hit the spot' and I like your clear and concise presentations using case study examples, very well done!"

"Thank you for a well organised and informative workshop"

"Very good to see a government organisation being so open and trying their best to interact with industry. Great work"

"Many thanks for organising the session, truly appreciated. Looking forward to the next one"

"Excellent initiative by the TGA, will highly recommend to colleagues"