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'Meeting your obligations' workshop Melbourne


3 September 2019

This workshop precedes TGA's GMP Forum 2019 in Melbourne. You can register for the GMP Forum at Second Industry Forum on Good Manufacturing Practice - GMP².

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

SME Assist 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 - Opportunity to ask general questions.

Product focus (subject to demand) - Various breakout sessions will be held 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 in a combined breakout session.

  1. How and why TGA monitors safety, efficacy and quality of therapeutic goods, and what 'conditions of approval' means and how this applies in practice
  2. What data and information you need to collect, hold and provide to meet your obligations as a sponsor, and how this can vary according to the type of good you are the sponsor for
  3. What other processes and requirements you need to meet, particularly with respect to:
    1. monitoring and reporting to the TGA, such as post-market monitoring requirements, manufacturing quality issues or other obligations associated with your product
    2. any changes in circumstances or other issues associated with you, the manufacture of your product (such as how they relate to licensing and Good Manufacturing Practice) and/or the product itself
    3. advertising, and/or any claims you may make with respect to your product
    4. the role of TGA, including your obligations (and our requirements) around product recalls
  4. Your legal and financial responsibilities, including:
    1. fees and charges; for example, application and evaluation fees or fees for inspections
    2. annual charges for all entries on the ARTG and annual licence charges, including how and where these apply
    3. other legal requirements; for example, those pertaining to product labelling
  5. The variations between sponsor requirements depending on the type of therapeutic good, such as for complementary medicines or different classes of medical devices

Event details

Afternoon tea will be provided. 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.

Register your interest