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Education and workshops

Foundation

16 January 2020

Navigating the regulatory maze can be a challenge, especially if you're new to regulation. SME Assist provides education and training on various topics to help small to medium enterprises (SMEs), researchers, start-ups and anyone who is unfamiliar with regulation understand how therapeutic goods are regulated in Australia.

'Meeting Your Obligations' workshops

Who should attend

This is 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:

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

*Note these are likely to be in a combined breakout session.

Learning objectives

Attendance at a workshop will:

  • help you to understand the role of TGA, how we regulate therapeutic goods and regulation basics
  • clarify your obligations as a sponsor including obtaining market authorisation and meeting advertising, manufacturing and post-market monitoring requirements (including adverse event reporting)
  • give you the opportunity to seek clarification on areas of regulation you may find unclear
  • equip you with the key regulatory requirements associated with your type of therapeutic good

Upcoming workshops

There are currently no scheduled workshops.

Please subscribe to our SME Assist email list to be notified of upcoming workshops once they are open for registration.

Presentations

You can find some video recordings from our 'Meeting your obligations' workshop below:

Webinar recordings

You can find some webinars on useful topics below:

TGA training and presentations

You can find other TGA training and presentations below: