TGA SME Assist Workshop: Meeting Your Obligations (Sydney)

Closed 22 Mar 2019

Opened 26 Feb 2019

Overview

This workshop is now at capacity. Please register your interest to assist in planning our next Sydney workshop (tentatively August 2019).

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

SME Assist, together with the Macquarie University Clinical Trials Unit, 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 specialists - 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 and over-the-counter medicines (e.g. vitamins, nutritional supplements, non-prescription medicines)
  • Prescription medicines (e.g. antibiotics, monoclonal antibodies)
  • Biologicals (e.g. tissue-based products, stem cells)

Event details

When: Wednesday 10 April 2019, 9:30am - 3:00pm

Where: Macquarie University, Room 801-03, 12 Wally’s Walk, Macquarie Park NSW

RSVP: Register your interest by Friday 22 March 2019*

*Registrations may close prior to 22 March if capacity is reached.

Morning tea and lunch 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.

What Happens Next

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

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