C3A: Recall Reforms – The Future of Market Actions
Tracks
Goldfields Theatre Breakout 1
| Tuesday, November 19, 2024 |
| 2:05 PM - 3:00 PM |
Details
As advancements in therapeutic goods technology continue to evolve the healthcare landscape, we need to make sure our regulatory processes remain contemporary and fit for purpose. In response to stakeholder feedback, we have reviewed and are making improvements to the way recalls are managed and communicated in Australia. In this session, you will hear about the next package of exciting reforms about to implemented, including Australia’s new recall terminologies and the outcomes from the review of our legislative recall powers.
Speaker: Craig Davies, Director, Recalls Section
Craig Davies joined the Therapeutic Goods Administration (TGA) in 1990. Since the early 2000s, he has managed sections with responsibility for advertising regulation, export medicine applications, the Adverse Drug Reactions System database and a range of international and national secretariat functions including the Global Harmonization Task Force and numerous TGA expert advisory committees. In 2016, Craig was appointed to his current position as Director of the Recalls Section in the Manufacturing Quality Branch. This Section is responsible for coordinating recall actions for therapeutic goods which are undertaken for goods already supplied to the market for which there are deficiencies in relation to their safety, quality, efficacy / performance, or presentation.
Speaker: Craig Davies, Director, Recalls Section
Craig Davies joined the Therapeutic Goods Administration (TGA) in 1990. Since the early 2000s, he has managed sections with responsibility for advertising regulation, export medicine applications, the Adverse Drug Reactions System database and a range of international and national secretariat functions including the Global Harmonization Task Force and numerous TGA expert advisory committees. In 2016, Craig was appointed to his current position as Director of the Recalls Section in the Manufacturing Quality Branch. This Section is responsible for coordinating recall actions for therapeutic goods which are undertaken for goods already supplied to the market for which there are deficiencies in relation to their safety, quality, efficacy / performance, or presentation.
