TGA SME Assist Workshop: Meeting Your Obligations (Perth)

Closes 13 Sep 2019

Opened 12 Aug 2019

Overview

Navigating the regulatory maze can be a challenge, especially if you're new to regulation. 

SME Assist in partnership with The Western Australian Health Translation Network 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

Basics of regulation - An overview of therapeutic goods regulation, TGA’s role and sponsor responsibilities when supplying  therapeutic goods in Australia.

Case studies - Explaining the general principles of market authorisation, manufacturing, advertising and post market vigilance as they relate to therapeutic goods.

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

Product focus (subject to demand) - Various breakout sessions will be held in the afternoon focusing on specific products. Please 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)*

*Note these are likely to be a combined product focus session.

Event details

When: Wednesday 25 September 2019, 9.00am – 12.30pm

Where: The Western Australia Health Translation Network, The University of Western Australia, 35 Stirling Hwy, Crawley WA

RSVP: Register your interest by Friday 13 September 2019

Morning 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 and training sessions.

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

Audiences

  • Academics
  • Businesses
  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Medical Devices & IVDs
  • Biogicals

Interests

  • Regulatory policy