WS5: How to do an Effective Recall (Repeat of WS1)
Tracks
Eureka Room 1 Workshop
| Wednesday, November 20, 2024 |
| 11:00 AM - 11:30 AM |
Details
We begin with a tale as old as time – your product, marketed for years without problem, is now a potential risk to consumers. What happens next? When reviewing sponsor’s recall notifications, the TGA isn’t simply looking to tick boxes. In this workshop we will explore real-life case studies and the information we need to assess before agreeing to your recall actions.
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.
