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Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus
The FDA is trying to learn all it can about quality metrics.
The agency began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect — and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation.
A scary prospect? Maybe.
A valuable opportunity? Almost definitely.
Mark your calendar for a strategy session with two knowledgeable industry activists, Steven Mendivil of Amgen and Denyse Baker of AstraZeneca. Over the course of fast-paced 90-minutes, they’ll explain the latest developments and what they mean for you. You’ll discover:
Quality metrics is no longer a distant dream. It’s coming — and you need to prepare your quality system to meet it.
Drug and biologics makers distributing Rx or OTC products within the U.S. or holding marketing authorizations with FDA (NDAs, ANDAs, BLAs). Specific job titles include but aren’t limited to:
Meet Your Presenters
Steven Mendivil is Senior Advisor for Quality/External Affairs at Amgen, where he formerly served as Executive Director of International Quality/External Affairs among other leadership positions during a 19-year stint with the major biotech firm. Previously he worked 15 years for Genentech, Syntex and SYVa in regulatory affairs, quality and manufacturing positions encompassing both drugs and devices.
Denyse Baker is Senior Policy Director-U.S. Regulatory Affairs for AstraZeneca, supporting policy development and advocacy on behalf of biosimilars, combination products and PDUFA VII. Over 30 years in pharma, she has held positions with the FDA (CDER) and Eli Lilly. She was a leader of the PDA’s Pharmaceutical Quality and Culture metrics programs, as well as coordinator for the PDA Regulatory Commenting and PDA Taskforces ,working on data integrity and post-approval change affecting drugmakers.
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