Meeting your obligations

Foundation

27 July 2017

Education and training to support small and medium enterprise

Introduction

As part of a program of support for Small to Medium Enterprises (SMEs), we have identified education and training topics that will help SMEs, and others who may not interact with us frequently or often, to understand key issues around the regulation of therapeutic goods in Australia.

Overview

The TGA regulates and monitors therapeutic goods supplied in Australia including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. This ranges from assessing applications to enter products in the Australian Register of Therapeutic Goods (ARTG), for clinical trials and for access to unapproved goods (for supply in Australia where they are not on the ARTG).

If you or your organisation imports, supplies, exports or manufactures a therapeutic good you have certain requirements and obligations to ensure your product is safe to use, meets its intended purpose and is making appropriate claims around its use.

This education session or package gives an overview of the role and responsibilities of sponsors at different stages of the regulation process.

Target audience

This topic is specifically targeted to those new to regulatory processes in the Australian environment. You will benefit from this material if you seek to be a sponsor of a therapeutic good, or you are a sponsor and need to understand your obligations.

Learning objectives

At the end of the education and training you should have a better understanding of the following:

  1. how and why the 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 GMP) and/or the product itself
    3. advertising, and/or any claims you may make with respect to your product
    4. the role of the 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
  6. Course outline

    The education and training will be delivered by TGA officers who are responsible for monitoring safety, efficacy and performance of therapeutic goods, as well as officers responsible for monitoring manufacturing quality and compliance with our requirements. It will include presentation material and case study examples, highlighting how the TGA requires sponsors to meet their obligations and how these obligations are applied in practice.

    Where courses are delivered face-to-face or in a live environment, you will have opportunities to ask questions and/or participate in group discussion.

    Course delivery

    We recognise it is important to deliver education and training in a number of ways. If there is sufficient interest, we will also:

    • deliver face-to-face workshops with a panel of experts and a facilitator (a half- or full-day session)
    • offer webinars and training packages via the SME Assist page on the TGA website
    • partner with other peak groups and stakeholders to deliver joint training at conferences, forums and other events.

    Under this topic, a range of courses will target different aspects of your obligations, particularly:

    • medical devices
    • prescription medicines
    • over-the-counter medicines
    • complementary medicines
    • biological medicines
    • biologicals (cell and tissue therapies).
    • This may also target different audiences and roles, such as:
    • sponsors
    • manufacturers
    • wholesalers
    • retailers

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    Event details

    As specific training dates and events are announced they will appear below: