Medicines, Medical Devices, IVD’s – The evolving world of combination products (T3)
Speaker/s
- Rodney Peters, Pharmacovigilance Manager, Baxter
- Pam Carter, Director, Signal Investigation – Devices, TGA
- David Davidson, Deputy Director, National Joint Replacement Registry (NJRR)
Chair
- Mike Flood, Principle, Locus Consulting
Synopsis
This session will relate the evolving regulatory frameworks for these combination products. The main discussion points will be around the challenges faced by manufacturers, sponsors and the TGA in the post market arena for these types of products in Australia.
Learnings
The session will explore the postmarket regulatory questions posed of the industry and the regulator for combination products, from both a medicines and medical devices perspective. It will consist of three short presentations offering both industry and TGA experiences on the issue, to inform the audience, and then an open discussion/workshop forum for both the panel and participants will follow.
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