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EU Restructuring PAT Team to Help Address Communication Challenges of the New Quality Paradigm

Aug 5th, 2010

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The EMA is restructuring its PAT Team to advance the team’s role in facilitating the communication within the agency and with industry needed to further the ICH Q8-10/QbD objectives.

The restructuring will involve a shift in both the team’s mandate and membership over the next year – a move aimed at helping integrate the disparate elements in the current EMA quality regulatory structure, AFSSAPS reviewer and PAT team member Kowid Ho told a CMC strategy forum on implementing quality by design cosponsored by the biotech science society CASSS and FDA in mid-July.

The biotech CMC strategy forums are held semiannually in the U.S. and once a year in Europe.  They are designed to bring industry and regulators together to drill down on specific quality topic areas deemed important in progressing biotech product regulation.  July’s meeting, held at the National Institutes of Health (NIH) in Bethesda, Md., was the third of the CMC strategy forums that has been focused on implementing QbD in the biotech context.  [Editor’s Note: The dialogue at the first two QbD forums is analyzed in the Sept./Oct 2007 and Sept./Oct 2008 IPQ reports, respectively.]

Recognizing the relative unfamiliarity of the US audience with the complexities of EU regulation and regulatory structures, Ho provided the history leading to the current situation, an explanation of how the system works, and the resulting need for changes to the PAT team to help support QbD implementation.

[Further discussion by Ho of the restructuring of the PAT team to help further communication across the complex EMA committee structure is provided for subscribers on page 2.]

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