3.6 TGA Decision Making and Appeals

Module 3.6 TGA Decision Making and Appeals forms part of the 3.0 Regulatory Requirements for Medical Technology.

Assists regulatory professionals understand the basis of the TGA’s regulatory decisions, as well as the requirements and procedures for appealing an ‘initial decision’ of the TGA.

Duration: Half day.

Learning outcomes

  • Understands the basics for submitting an application to the TGA.
  • Understands the principles of best practice decision making in the context of administrative decisions made by Government agencies
  • Identifies the types of decisions made by the TGA for medical devices
  • Understands which TGA decisions can be reviewed (appealed)
  • Explores the different mechanisms for appealing a TGA decision
  • Understands the rights and responsibilities of the applicant when seeking a review under section 60 of the Therapeutic Goods Act, or through the Administrative Appeals Tribunal (AAT).

Who should attend? 

Regulatory affairs professionals responsible for the submission of applications to the TGA should attend the training.  Module 3.5 Submitting Applications to the TGA or equivalent industry experience are the recommended pre-requisites for this Level 2 module.

How much does it cost? 

The cost of this half day module including GST is $550 for members and $895 for non-members. Once payment is accepted, applicants will be registered. Standard credit card fees apply.

How do I register?

This module has not been scheduled. To register your interest, please click on the Register Your Interest button below. Once sheduled, payment must be made by Credit Card (Visa, MasterCard or American Express) at the time of booking. Credit card payments are processed via our secure registration provider, Securepay.

Changes & cancellations

Cancellations for all face-to-face training and events will be accepted up to five business days prior to the training and are subject to a cancellation fee of $50. Attendees from the same organisation may be swapped up to two working days prior to the training if MTAA is advised and agrees in writing. No refunds are issued for cancellations after this time. Please note, cancellations where payments were made online by credit card will be refunded less credit card fee(s).

If a cancellation is made less than five days prior to an event, without prior notice or substitution, there will be no refund. Should MTAA cancel an event, a full refund will be made.

To make a cancellation or swap an attendee, please contact reception by P: +612 9900 0650 or E: pd@mtaa.org.au

Tax invoice

You will be emailed a paid tax invoice once payment is complete. A copy of all your transactions are also available in your Transaction History tab on your My MTAA Account and can be viewed here anytime.

For further information please E: pd@mtaa.org.au

Contact Information

Lee Grow

Additional Information