Webinar
International Regulatory Convergence for Medical Devices and In-Vitro Diagnostics
| On-Demand | 1 Hour | Your Desk! |
| On-Demand | 1 Hour | Your Desk! |
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Tracey DuffyHead of the Medical Devices and Product Quality Division, Health Products Regulation Group |
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Jean BoudaudHead of Medical Device/IVD Consulting, PharmaLex Australia |
Ongoing efforts toward regulatory convergence are critical in maximizing alignment of medical device technical regulations and guidelines around the world. Regulatory convergence can benefit the entire healthcare eco-system, ultimately contributing to faster access to new, safe and efficacious technologies for patients in need.
However, convergence must also account for differences around the world in patient demographics, healthcare systems, local legislations and the several millions of different types of medical devices in circulation.
In 2011, the TGA was a founding member of the International Medical Device Regulators Forum (IMDRF), building on the strong foundations from the Global Harmonization Task Force (GHTF) on Medical Devices.
For this session, we invited Tracey Duffy, First Assistant Secretary of the Medical Devices and Product Quality Division at the TGA and former Chair of IMDRF, and our expert Jean Boudaud, Head of Medical Device/IVD Consulting at PharmaLex, to discuss with us some important considerations in the implementation of international regulatory convergence for medical devices.