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ISPE Announces Plans for Its Drug Shortages Initiative through 2014
Date:11/2/2013

TAMPA, Fla., Nov. 2, 2013 /PRNewswire/ -- ISPE today announced a lineup of activities that will bring pharmaceutical industry stakeholders together several times in the coming year to address the issues leading to shortages in the global drug supply. Beginning Monday 4 November 2013 the Society will offer a series of education sessions, training and roundtable events for industry leaders and regulators. These meetings will focus on addressing the results of ISPE's 2013 Drug Shortages Survey, the findings of follow up research, and pathways to improving processes that could mitigate or avoid shortages.

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The series of events will begin with the ISPE Drug Shortages Task Force progress report Monday at ISPE's Annual Meeting in Washington, DC. The didactic portion of the session will focus on the possible connection between drug shortages and the lengthy chemistry, manufacturing, and control (CMC) process; a description of key operational elements in manufacturing that appear critical to avoiding shortages will also be provided. During the interactive portion of the session, Captain Valerie Jensen, R.Ph., Associate Director for FDA's Center for Drug Evaluation and Research's (CDER's) Drug Shortage Program, will join a panel hosted by ISPE for a question and answer session with the audience. Captain Jensen's participation on the panel comes just four days after the release FDA's Strategic Plan for Preventing and Mitigating Drug Shortages.

The full ISPE Drug Shortages event schedule for 2014 includes:FebruaryIndustry Roundtable: Keys to Addressing Quality System Issues in Aseptic Manufacturing which May Lead to Shortages

 ISPE Aseptic Annual Conference Date: 24-25 February 2014

 Location: Washington, D.C., USAA
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