About the Event

Navigating the regulatory maze can be a challenge, especially if you're new to regulation. To help, the Therapeutic Goods Administration (TGA) SME Assist presents “Meeting your Obligations” a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.

If you have a product or medicine 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:

Fundamentals of regulation

During this session, we’ll cover an overview of therapeutic goods regulation, including TGA’s role, the steps to seek market authorisation and helpful links for applications.

Product focus sessions (concurrent sessions)

1. Medical devices (e.g. surgical instruments, bandages)
2. Complementary medicines (e.g. vitamins, nutritional supplements)

Medical devices and complimentary medicines are two areas which generate high innovation from business. To help potential applicants, each product focus session will provide:

• an overview on the general principles and criteria for regulation
• the steps involved to progress an application
• an understanding of the regulatory considerations for manufacturing a product
• the requirements to manage and maintain a product on the ARTG
• an overview of how the TGA monitors ongoing compliance.

Panel Discussion

During this session, our panel will share their thoughts on how business can best navigate the commercialisation journey, pitfalls to avoid, how and when to seek out different support and guidance as well as answer questions from the audience.

Panel members

• Ben Noyen – Assistant Secretary, Regulatory Engagement Branch, TGA
• Jeremy Barker – AusIndustry, Department of Industry, Science and Resources
• Industry Speaker – TBC

Event details

• When: Tuesday, 20 September 2022
• Where: Brisbane Convention Centre
• Time: 9:00am-2:30pm

To participate in this in-person workshop, register online via the TGA website.

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