TGA SME Assist Workshop: Meeting Your Obligations (Sydney)

Closed 17 Feb 2020

Opened 24 Jan 2020

Overview

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, TGA’s role 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 (subject to demand) - sessions focusing on the various types of therapeutic goods. Nominate your area of interest when you register:

  • Medical devices (e.g. surgical instruments, bandages)
  • Complementary medicines (e.g. vitamins, nutritional supplements)
  • Prescription medicines (e.g. antibiotics, monoclonal antibodies)
  • Biologicals (e.g. tissue-based products, stem cells)
  • Over the counter medicines (e.g. paracetamol, lozenges)

Event details

When: Tuesday 25 February 2020, 1:00pm- 4:30pm

Where: The University of New South Wales (UNSW), John Niland Scientia Building, Library Rd Kensington NSW 2052

RSVP: Register your interest by Monday 17 February 2020

Afternoon tea will be provided. Due to limited spaces, invitations are open to a maximum of two representatives per organisation. Please note that registration is tentative. Places will be confirmed by email closer to the date.

About SME Assist

TGA's SME Assist service is designed to help SMEs better understand therapeutic goods regulation in Australia. We provide access to articles, interactive tools and education sessions.

If you have any questions about this event, please contact us at sme.assist@tga.gov.au / 1800 020 653.

What happens next

Thank you for your interest. Registrations have now closed for SME Assist's Meeting Your Obligations workshop.

If you would still like to attend, please contact us at sme.assist@tga.gov.au / 1800 020 653 as some places may still be available.

To keep up-to-date with the latest SME Assist events, please visit our website and subscribe to our mailing list. 

SME Assist

www.tga.gov.au/sme-assist

sme.assist@tga.gov.au / 1800 020 653

Audiences

  • Academics
  • Businesses
  • Prescription medicines
  • Complementary medicines
  • Medical Devices & IVDs
  • Biogicals

Interests

  • Regulatory policy