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SHOWCASE FEATURE: Regulatory Affairs: Regulating the Globe

$30.00

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Product Description

The FDA report, Pathway to Global Product Safety and Quality, has recommended a dramatic shift in strategy, calling for the agency to act globally to help ensure safety and quality of imported products, including forming partnerships with regulatory agencies around the globe.
According to Sherry Keramidas, Ph.D., executive director of the Regulatory Affairs Professionals Society (RAPS), the FDA’s recent increased focus on operations outside the United States is a logical response to the globalization of the healthcare product sector. However, she notes, emphasis on international…

Sidebars:
Prior Professional Experience
Compensation on the Rise for ­Healthcare Regulatory Professionals
Building a Benefit-Risk Framework
Common Elements of the Core UMBRA Benefit-Risk Framework
VIEWPOINTS
Ken Phelps
, CEO/President, Carmargo Pharmaceutical Services
Greg Kain, Manager, Integrated Project ­Management Company

Experts
Mark De Rosch, Ph.D.
VP, ­Regulatory Affairs, Inspiration ­Biopharmaceuticals Inc., a ­biopharmaceutical company focused solely on serving the hemophilia community. For more information, visit inspirationbio.com.
Sherry Keramidas, Ph.D. ­Executive Director, Regulatory Affairs Professionals Society, a global ­organization of and for those involved with the regulation of healthcare and related products, including medical devices, ­pharmaceuticals, biologics, and nutritional ­products. For more information, visit raps.org.
Len Lescosky, J.D. Divisional VP, Chemistry, Manufacturing & Controls, Regulatory Affairs, Pharmaceutical Products Group, Abbott ­Laboratories, a global, broad-based healthcare company devoted to discovering new medicines, new technologies, and new ways to manage health. For more information, visit abbott.com.
Lawrence Liberti. Executive ­Director, CIRS — Centre for Innovation in Regulatory Science Ltd., a think tank through which the international ­pharma industry, regulatory authorities, and ­academia meet, debate, and develop regulatory and HTA policy. For more information, visit cirsci.org.

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