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NSW Department of Industry

10 Valentine Avenue

Parramatta, NSW 2150

Australia

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Event description

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Assisting SMEs to understand medicines regulation in Australia.


Navigating the regulatory maze is a challenge for many small to medium businesses (SMEs).

This free workshop will assist SMEs or those new to regulation in Australia by providing an overview of the roles and responsibilities of sponsors of medicines at different stages of the regulation process.

The course content is aimed at people with a beginner/introductory level of understanding of therapeutic goods regulation in Australia.

This workshop is focussed on medicines.



Session One

Regulation basics, including the role of the TGA, market authorisation and common terms and concepts that will help you understand your obligations.


Session Two

Requirements and obligations that are common across all types of therapeutic goods, including advertising, adverse events and product recalls.


Breakout Session (select one)

  1. Non-prescription medicines (complementary and OTC)

  2. Prescription medicines


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.



Learning Objectives

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

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

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

What other processes and requirements you need to meet, particularly with respect to:

  • monitoring and reporting to the TGA, such as post-market monitoring requirements, manufacturing quality issues or other obligations associated with your product

  • 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

  • advertising, and/or any claims you may make with respect to your product

  • the role of the TGA, including your obligations (and our requirements) around product recalls

Your legal and financial responsibilities, including:

  • fees and charges; for example, application and evaluation fees or fees for inspections

  • annual charges for all entries on the ARTG and annual licence charges, including how and where these apply

  • other legal requirements; for example, those pertaining to product labelling

The variations between sponsor requirements depending on the type of therapeutic good, such as for complementary medicines or different classes of medical devices



Numbers are restricted to a maximum of TWO representatives per organistation.

This is a free event hosted by the Department of Health (Theraputic Goods Administration) in collaboration with the Department of Industry, Innovation and Science Entrepreneur's Programme.


If you have any questions about this event or any future events, please contact EPLearningEvents@industry.gov.au


About SME Assist

Therapeutic goods regulation and legislation can be challenging to navigate. SME Assist is a new service designed to help SMEs better understand therapeutic goods regulation in Australia. They provide access to articles, interactive tools and education and training sessions.

www.tga.gov.au/sme-assist

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NSW Department of Industry

10 Valentine Avenue

Parramatta, NSW 2150

Australia

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