TGA SME Assist Workshop: Meeting your obligations - Melbourne

Closed 16 May 2018

Opened 23 Apr 2018

Overview

Navigating the regulatory maze is a challenge for many small and medium enterprises (SMEs).

Meeting Your Obligations, presented by SME Assist, is a free full-day workshop to help SMEs and those new to therapeutic goods regulation in Australia understand their responsibilities at different stages of the regulation process.

The course content will focus on medicines and medical devices, and is aimed at beginners who are new to therapeutic goods regulation.  

Workshop program

Part I – Basics

An overview of therapeutic good regulation, including the role of the TGA, market authorisation and common terms and concepts.

Part II – Case Studies

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

Part III – Breakouts

Select one preferred breakout session when registering.

  1. Complementary medicines
  2. Prescription medicines
  3. Medical devices

Details

Date and time

Location

Register

Tuesday, 29 May 2018
9:00am – 5:00pm

Karstens Conference Centre
123 Queen Street, Melbourne 3000

Register your interest by Wednesday 16 May 2018

Due to limited spaces, invitations are restricted to a maximum of TWO representatives per organisation. Please note that registration is tentative. Places will be confirmed by email.

About SME Assist

SME Assist is TGA’s new service designed to help SMEs better understand therapeutic goods regulation in Australia. We provide access to articles, interactive tools and education and training sessions.

If you have any questions about this event, please contact us on sme.assist@tga.gov.au / 1800 020 653.

What Happens Next

Registrations have now closed for the SME Assist workshop on Meeting your obligations.

Thank you for your interest. Please visit the TGA website for updates on SME Assist and upcoming events.

Contact for enquiries:

SME Assist

E: sme.assist@tga.gov.au

P: 1800 020 653

Audiences

  • Non-government organisations
  • Businesses
  • Prescription medicines
  • Complementary medicines
  • Medical Devices & IVDs

Interests

  • Regulatory policy
  • Learning and development