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.
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 definitions of some of these metrics so as we move forward at least that is not a barrier."
"We already had a discussion within PDA to do a blinded survey of these draft metrics that we are going to pull together so that companies can self-report and we can share the results in a blinded way with companies --a beta test to see if we identified things that are going to be meaningful to differentiate."
Johnson noted PDA's readiness to conduct a pilot program to identify issues and challenges that would need to be addressed prior to the rollout of an official U.S. FDA metrics program.
The data from the survey and the pilot will be used to help assess the robustness of the proposed definitions, the ease and availability in which the data is collected, and the knowledge and value gained from the data reported.
Finally, Johnson indicated that PDA is considering a follow-up Pharmaceutical Quality Metrics Conference in 2014.
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its nearly 10,000 members worldwide. PDA's Annual Meeting will be held April 7-9, 2014 in San Antonio, Texas. For information, visit www.pda.org and follow PDA on LinkedIn.
Director of Marketing Services, Parenteral Drug Association® (PDA)
(301)656-5900 ext. 153
|SOURCE Parenteral Drug Association|
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