Navigating the regulatory maze can be a challenge, especially if you're new to regulation.
SME Assist provides workshops on various topics to help small to medium enterprises (SMEs), researchers, start-ups and anyone who is unfamiliar with regulation understand how therapeutic goods are regulated in Australia.
Who should attend
This is a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation. This may include:
small to medium enterprises (SMEs)
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.
What is covered
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: Q&A with TGA staff - opportunity to ask general questions.
Feedback from previous workshop attendees
"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"
SME Assist provides webinars on various topics to help small to medium enterprises (SMEs), researchers, start-ups and anyone who is unfamiliar with regulation understand how therapeutic goods are regulated in Australia.
A new codeine fact sheet for physiotherapists is now available.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.