SME educational topic: How we assess a product

Foundation

9 June 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 and tissue 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).

This education and training package will cover how the TGA assesses an application for a product to be entered on the ARTG and help inform you of the considerations we apply when undertaking an assessment.

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 are looking at applying for a product to be entered on the ARTG (or are currently conducting research/clinical trials and may want to understand how a product is considered by the TGA), and would like to understand:

  • the different approaches we take according to the type of therapeutic good
  • how the assessment process works, including what you may be asked to provide or do
  • some of the common pitfalls/mistakes that you can avoid in putting in a submission to us.

Learning objectives

At the end of this training you should have a better understanding of:

  1. the steps and processes involved in assessing an application that is received by the TGA
  2. how the TGA assesses an application seeking pre-market approval, including:
    1. the broader considerations that are applied in assessing a submission
    2. how a risk-based classification approach informs our consideration of the standard, level and quality of evidence required to make a determination
  3. Common pitfalls, mistakes and issues in the applications we receive, which can impact on the timely consideration of your application and lead us to seek further clarification from you
  4. Some of the additional considerations that inform decision-making, particularly with respect to:
    1. labelling, product information, consumer information and other information provided with the product
    2. requirements that may be established, such as Risk Management Plans and other conditions that may be imposed at the time of the decision.

Course outline

The education and training will include case studies. TGA officers who are specially trained in undertaking assessments will walk through these case studies, highlighting how these examples would be assessed, the level of evidence expected, and what the likely requirements would be were the case study examples approved for listing or registration or inclusion on the ARTG.

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 through the SME Support service page on the TGA website
  • partner with other peak groups and stakeholders to deliver joint training at conferences, forums and other events.

Courses will target different aspects of our assessment processes, particularly:

  • medical devices
  • prescription medicines
  • over-the-counter medicines
  • complementary medicines
  • biological medicine sponsors
  • biologicals.

Register your interest

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Event details

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

Date: Location: Cost:
TBH TBH TBH