TGA SME Assist Workshop: Meeting your obligations - Sydney

Closes 13 Jun 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

Monday, 25 June 2018
9:00am – 5:00pm

Karstens Conference Centre
111 Harrington St, The Rocks NSW 2000

Register your interest by Wednesday 13 June 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.

Audiences

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

Interests

  • Regulatory policy
  • Learning and development