Seminars Conferences and Workshops:EOIs requested for interest in TGA Meeting Your Obligations workshop

Seminars Conferences and WorkshopsEOIs requested for interest in TGA Meeting Your Obligations workshop

The Therapeutic Goods Administration (TGA) is currently seeking Expressions of Interest for a potential Meeting Your Obligations workshop to be held in Adelaide in November this year.

As navigating the regulatory maze can be a challenge, especially if you're new to regulation, this free, full-day workshop is aimed at beginners who are unfamiliar with therapeutic goods regulation.

SME Assist is a relatively new service that TGA has launched to assist SMEs, researchers, start-ups and those developing new medicines and medical devices that are unfamiliar with therapeutic goods regulation to help them understand their requirements.

To register your interest, please email Marina Delpin, Program Manager: Researcher Professional Development.

If you are making therapeutic claims about a product or have a product that is likely to be considered a therapeutic good, this full-day workshop will help you understand your responsibilities at different stages of the regulation process.

What will be covered

Part I - Basics

An overview of therapeutic goods regulation, including TGA's role, market authorisation and common terms you will encounter when engaging with us.

Part II - Case studies

Case study analyses that cover requirements and obligations that are common across all types of therapeutic goods, including advertising, adverse events and product recalls. These are followed by a Q&A session with TGA specialists.

Part III - Breakouts

Breakout sessions that focus on different specialty areas, depending upon interest. Options are provided when you register online.

Learning objectives

How and why 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:
a. monitoring and reporting to the TGA, such as post-market monitoring requirements, manufacturing quality issues or other obligations associated with your product
b. 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
c. advertising, and/or any claims you may make with respect to your product
d. the role of TGA, including your obligations (and our requirements) around product recalls
Your legal and financial responsibilities, including:
a. fees and charges; for example, application and evaluation fees or fees for inspections
b. annual charges for all entries on the ARTG and annual licence charges, including how and where these apply
c. 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

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