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Pharmaceutical Quality Metrics Conference Shapes PDA Metrics Agenda
Date:12/19/2013

BETHESDA, Md., Dec. 19, 2013 /PRNewswire-USNewswire/ -- The Parenteral Drug Association, Inc. (PDA) held a well-attended and received, interactive 2013 PDA Pharmaceutical Quality Metrics Conference, Dec. 9-10 in Bethesda, Md.

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Over 300 industry experts on drug product quality and manufacturing assembled to participate in breakout discussions and select the most important and useful quality metrics. The interactive sessions were set up to assist a PDA task force draft a points to consider report on pharmaceutical quality metrics, which PDA intends to submit to the U.S. FDA in December.

A large number of CDER officials also attended the meeting, including Director Janet Woodcock.

Woodcock took the podium in the closing session and thanked PDA for holding the workshop.

"This is really important. We are having an ongoing dialogue about this issue of metrics. I was able to come and listen to the report-out from the polls and breakout sessions. I was very intrigued by both the engagement and what people actually said about what is going on. It gave me a lot of hope that we can really make this happen," she said.

In closing the conference, PDA President Richard Johnson assured participants that the feedback received greatly helped the PDA task force refine its points to consider report, which will be sent to the U.S. FDA before the end of 2013.

"Whatever the team was thinking before the meeting, I can assure you it is different today....If it was easy, we wouldn't need a meeting."

Moving forward, Johnson pledged that PDA "will invite and try to work with other organizations in the coming year to harmonize specifically some definitio
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SOURCE Parenteral Drug Association
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