Event
TGA SME Assist Workshop: Meeting Your Obligations
- 03 Mar 2022
- 08:45AM
- Save to my Calendar
- Brisbane & Online, Brisbane Convention & Exhibition Centre, Australia
About the Event
Navigating the regulatory maze can be a challenge, especially if you're new to regulation.
SME Assist presents Meeting Your Obligations: a free workshop aimed at beginners who are unfamiliar with 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.
What will be 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.
PART IV: Product focus session (subject to demand) - various sessions focusing on specific product types.
- When: Thursday 3 March 2022
- Online attendance: 9.00am – 11.30am (AEST)
- In person attendance: 8.45am - 12.30pm (AEST)
- Where: Brisbane Convention & Exhibition Centre, Glenelg St, South Brisbane, Queensland
Run by Therapeutic Goods Administration, Australian Government Department of Health - Please click here to register and for more event information.