TGA SME Assist Workshop: Meeting Your Obligations (Perth)

Closes 12 Oct 2018

Opened 6 Sep 2018

Overview

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

‘Meeting Your Obligations’ is a free workshop presented by SME Assist that is 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 full-day workshop will help you understand your responsibilities at different stages of the regulation process.

What will be covered

Part I – Basics

An overview of therapeutic goods regulation, including TGA’s role, market authorisation and common terms you will encounter when engaging with us.

Part II – Case Studies

Case study analyses that cover requirements and obligations common across all types of therapeutic goods, including advertising, adverse events and product recalls. These are followed by a Q&A session with TGA specialists.

Part III – Breakouts (via videoconference)

Upon registering your interest, you will be given the opportunity to nominate one specialty area:

  1. Biologicals
  2. Medical devices
  3. Complementary medicines
  4. Prescription medicines

Part III of the workshop will consist of breakout sessions focusing on these different areas, depending upon interest. 

Event details

When: Friday 26 October 2018, 9:00am - 4:00pm

Where: Cliftons, Parmelia House, 191 St Georges Terrace, Perth WA 6000

RSVP: Register your interest by Friday 12 October 2018

Due to limited spaces, invitations are restricted to a maximum of TWO representatives per organisation. Please note that registration is tentative. Places will be confirmed by email.

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
  • Medical Devices & IVDs
  • Biogicals

Interests

  • Regulatory policy