Summary
View this on-demand webinar to understand the impact that new regulations are having on the medical device and diagnostic industry and get insights into how Ascensia Diabetes Care and Roche Diagnostics are transforming regulatory compliance in their organizations. You'll get insights into:
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Why the urgency to prepare for new regulations
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Primary challenges and drivers for transitioning to an agile operations model
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Key efficiencies in transforming to an agile operations model
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Key strategies for better global compliance
Speakers
Roxane Bonner - QA/RA Program Director, Roche Diagnostics
Roxane is the QA/RA Program Director for Roche Diagnostics managing varying responsibilities across regulatory affairs, quality systems, project management, product development and change management for in vitro diagnostics and medical devices. Prior to Roche, she spent fifteen years as a Molecular Biologist at the University of Arizona, Motorola Life Sciences and GE Healthcare.
Terri Howard - Director, Regulatory and Commercial Strategy, Veeva Systems
Terri has more than 20 years of experience in life sciences, with the last decade focused on regulated content management technology for the medical device industry. She has worked with industry leadership teams to form and influence change in regulatory and marketing business practices, most recently at CareFusion, now BD. Howard joined Veeva Systems in 2015 as director of strategy to help medical device companies leverage cloud technology to bring products to market faster and more efficiently.
Brian Truchan - Head of Pre-Market Regulatory Affairs, Ascensia Diabetes Care
Brian is the Head of Pre-Market Regulatory Affairs for Ascensia Diabetes Care responsible for leading the Pre-Market Regulatory Affairs function in the development, alignment and implementation of regulatory strategies to obtain market access for new in vitro diagnostics and medical devices. Brian has over 15 years of RA experience in active implantable medical devices, combination products, and pharmaceuticals, most recently at Merck & Co.