ISPE Confirms Participation at FDA/PQRI Conference

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ISPE Confirms Participation at FDA/PQRI Conference
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(TAMPA, FLORIDA, USA, 13 August 2014). The International Society for Pharmaceutical Engineering (ISPE) and the Product Quality Research Institute (PQRI) are pleased to announce that ISPE will participate in the upcoming FDA/PQRI Conference on Evolving Product Quality
16 – 17 September 2014 in Bethesda, MD. The conference will examine topics crucial to improving drug product and patient safety— quality assessments, international harmonization, breakthrough therapies, ICH, risk management techniques and quality metrics. ISPE will join a distinguished lineup of industry leaders and more than 21 FDA regulators who will be presenting at the conference.

During the PQRI event, ISPE will provide an update on its Quality Metrics Pilot, a program created to provide a balanced objective view of quality performance within a site. Since it began, the Pilot has achieved significant enrollment from the pharmaceutical community, including representatives from the generic, innovator, over-the-counter, contract manufacturing and analytical businesses. Following the education sessions on 16 September, ISPE will co-host a reception from 6:30 – 8:00 pm for the conference attendees.

“Supporting the FDA/PQRI Conference this year is key to ISPE’s strategy of disseminating technical information on manufacturing and quality topics,” said Nancy Berg, ISPE President and CEO. “PQRI has been a strong contributor to the technical dialog that ISPE Members and their companies depend on in producing safe and effective medicines.”

“We appreciate the leadership of ISPE and its support of our upcoming event and reception,” said Rachael Roehrig, Chair, PQRI Steering Committee. “Support from our organizational members and sponsors enables PQRI to deliver high quality technical content and foster world class discussions.”

The conference schedule incorporates four concurrent themes over the two days: Risk Management and Quality Metrics, Performance-based Quality Assessment, Innovation in Manufacturing and Regulatory Assessment and Emerging Topics. For additional conference information, visit http://www.pqri.org.

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