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Join Amanda Maxwell, Regulatory Affairs Editor, David Filmore, Executive Editor, and Ashley Yeo, Principal Analyst of MedTech Insight for a look at medical device (MDR) regulation and the key changes in the US and European medical device markets that are sure to change the industry worldwide in the months and years to come.
Topics covered include an overview of the US and EU medical device regulatory markets and the changes that will take place; the FDA’s shift in focus and how this powerful organization has made improvements in their efficiencies; real-world data and its uses; nascent regulatory mechanisms and key regulatory players; and howmedical device manufacturers must prepare in the face of future regulation of medical devices and IVDs.
The session closes with a discussion of the Dalli Plan of Joint Actions, and an insightful update on the UK and Brexit.
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In Vivo: strategic insights for life sciences decision-maker...
Pharma Intelligence offers a wealth of pharmaceutical industry news and strategic insight into the healthcare & biotechnology markets from around the world. Working in an interconnected global network, our 65 journalists and over 300 in-house analysts supply comprehensive analysis and reports.
Scrip: industry news and insights
The Swiss major's pharma chief tells Scrip that its gene therapy for SMA offers much more than Biogen's Spinraza for both patients and payers, noting that the company is ready with alternative payment models for the pricey treatment as soon as approvals for Zolgensma are granted.
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Scrip: industry news and insights
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