You are here

SME Assist workshops and events

23 June 2021

SME Assist holds regular events including workshops and webinars which provide information about therapeutic goods regulation.

Upcoming events

There are no events currently scheduled.

Please subscribe to our SME Assist email list to be notified of upcoming events.

'Meeting Your Obligations' workshops

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.

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

Attendance at a workshop will:

  • help you understand the role of TGA, how we regulate therapeutic goods and regulation basics
  • clarify your obligations as a sponsor including obtaining market authorisation and meeting advertising, manufacturing and post-market monitoring requirements (including adverse event reporting)
  • give you the opportunity to seek clarification on areas of regulation you may find unclear

"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"

Webinars

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.

Please visit our previous webinars at Educational videos.