Quality Metrics Redux - Webinar Recording/Transcript

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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:

  • How the pilot program is progressing and what the FDA has learned so far
  • How to take advantage of opportunities to provide input to the FDA before it drafts regulations to implement the program, including contact with appropriate agency personnel
  • Important details of the FDA’s latest draft guidance on quality metrics, including what information is to be included in a meeting request and what information FDA would like to see during a site visit
  • Major industry concerns, such as metrics selection and definitions, and how the agency is addressing them
  • And much more

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:

  • Quality executives
  • Regulatory/compliance
  • Manufacturing/operations

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.