NATA in conjunction with TGA have planned 3 information sessions which will enhance the corporate knowledge base of facilities with the TGA IVD Regulatory Framework.
The sessions will also introduce new TGA initiatives.
These will be run as a series, and you are encouraged to attend all three free information sessions.
Session 1: Tuesday 12th March 2024, 12.30pm – 1.30pm
Refresher on In-house IVD Regulatory framework
Presenter: Shraddha Swami
Director, Devices In Vitro Diagnostics Section, Medical Device Authorisation Branch
Session 2: Thursday 14th March 2024, 12.30pm – 1.30pm
Data requirements and assessment approach – including Companion Diagnostics
Presenter: Rebecca Coorey
Senior Evaluator, Devices In Vitro Diagnostics Section, Medical Device Authorisation Branch
Session 3: Tuesday 19th March 2024, 12.30pm – 1.30pm
Introduction of new In-house IVD notification form
Presenter: Euan Miller
Assistant Director, Devices In Vitro Diagnostics Section, Medical Device Authorisation Branch
Note: These sessions will be recorded.
Once you register, you will receive the Teams link to the session.
If you have any questions ahead of this session, please direct them to: NATATGAIVD@nata.com.au