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Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations. Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations. Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow pharmacovigilance principles. In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional pharmacovigilance activities of pharmaceutical companies.
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