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'Meeting Your Obligations' workshops

Foundation

14 February 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.

Who should attend

This is a free workshop aimed at beginners who are unfamiliar with or new to 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

Sydney

Our next workshop will be held in partnership with the University of New South Wales (UNSW).

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

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

Live stream: Parts I, II and III of this workshop will be live streamed

RSVP: There are two registration options:

  1. Register your interest to attend the event in-person in Sydney by Monday 17 February 2020

    OR

  2. Register your interest to view the workshop via live stream

For those who are attending the event in person:

  • due to limited spaces, invitations are open to one or two representatives per organisation
  • please note that registration is tentative. Places will be confirmed by email closer to the date
  • this workshop is being filmed and live streamed (terms and conditions outlined at registration)
  • afternoon tea will be provided

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

Feedback from previous workshop attendees

"It was a very well planned and executed event. I thought the presentations 'hit the spot' and I like your clear and concise presentations using case study examples, very well done!"

"Thank you for a well organised and informative workshop"

"Very good to see a government organisation being so open and trying their best to interact with industry. Great work"

"Many thanks for organising the session, truly appreciated. Looking forward to the next one"

"Excellent initiative by the TGA, will highly recommend to colleagues"