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Thermo Fisher VP Wants More IVD Firms Involved In FDA's Manufacturing Maturity Program (Even Though His Company Isn't)
Peter Shearstone, VP of global quality assurance and regulatory affairs at in vitro diagnostic test-maker Thermo Fisher Scientific, is dismayed that only two IVD manufacturers are playing in the US FDA's Case for Quality Voluntary Improvement Program to measure manufacturing maturity and quality – and his firm isn't one of them. "Part of my challenge is moving my company toward proactivity, and if [CFQ VIP] can help do that, then I'd be hypocritical if I didn't embrace it," he says.
It may often seem like Brexit is the only story in town in the UK, but within health care and medtech a lot of system transformation and future planning for access to medtech innovation is underway, as this installment of Medtech Insight's Device Week podcast with Ashley Yeo and Amanda Maxwell underlines.
The “what” and the “how” involved in bringing medical technology to market for adoption by health-care systems is changing fast. The UK is laying the groundwork to be a global medtech innovation champion with two new tools: NHS England’s Long Term Plan and the newly boosted Accelerated Access Collaborative. The AAC's first chief executive, Sam Roberts, has been profiling her role in this prospective UK market access transformation.
The coming of spring has seen the announcement of multiple executive moves in the Asia Pacific region, including a new CEO at Japan's Daiichi Sankyo, while WuXi Apptec and llumina have also made new appointments. Other personnel changes also take place at Shionogi Healthcare and the top of Japan's main regulatory agency.
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