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Senior Director of Global Regulatory Policy
AstraZeneca
Denyse Baker is Senior Director of Global Regulatory Policy with AstraZeneca. She is passionate about connecting and collaborating to promote the importance of science-based regulation and organizational quality culture as foundations for delivering high quality products to patients. Denyse brings a strong technical foundation to her policy work with experience in engineering, manufacturing, quality and regulatory for small molecules, biologics and devices. Her work experience prior to AZ, includes US FDA, the Parenteral Drug Association, and Eli Lilly and Company. She is Vice Chair of PDA’s Regulatory and Quality Advisory Board, Co-leader of the Quality Management Maturity Task Force, member of the Quality Culture Assessment ANSI Standard Working Group and has trained over 100 regulators on the PDA Quality Culture Assessment Tool. Denyse is also secretary to the FDA Alumni Association Board of Directors. Denyse earned a B.S in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and holds RAC certifications in US and EU reg. affairs.
Tuesday, September 28, 2021
08:30 – 09:30 EDT
Tuesday, September 28, 2021
09:00 – 09:30 EDT