International Society for Pharmaceutical Engineering (ISPE), in conjunction with McKinsey & Co., will release preliminary data and findings from its Quality Metrics Pilot Program at the ISPE Quality Metrics Summit on April 21–22 in Baltimore.
Responding to FDA’s call for quality metrics, the Summit will be an effective vehicle for communication between Industry and FDA. The pilot data and findings will provide insight on what may be collected, how it may impact how pharmaceutical companies are regulated, and how quality might be measured.
During the summit, participants will hear case studies from some of the 18 companies and 44 individual sites, representative of generic, innovator, over-the-counter, and contract manufacturing organizations, who participated in the pilot. Summit participants will gain insights into the benefits and challenges experienced during the pilot in order to apply these learnings to quality metrics programs within their own firms.
Participants will also be able to actively participate and respond to the findings. Attendees will receive a copy of the final Quality Metrics Pilot Report in advance of the general public once it has been finalized.
“Not only will attendees be the first to view the data outcomes of the pilot program,” said ISPE president and CEO John Bournas, “this comprehensive and timely summit also serves as a forum for collaboration between industry and regulators. This is a high profile initiative intended to gauge pharmaceutical quality and promote continual improvement to proactively reduce drug shortages.”
The Summit program, co-chaired by Russell Wesdyk, FDA/CDER/OPQ, acting deputy director, Office of Surveillance; Mary Malarkey, FDA/CBER/OMPT, director, Office of Compliance and Biologics Quality, and Diane Hagerty, vice president, quality systems and processes, Genentech Inc., will feature report outs from the ISPE Quality Metrics Team and senior company leaders, as well as panels and workshops with regulators and a cross-section of pharmaceutical manufacturing companies from innovator, generic, OTC etc. from around the globe.
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