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From: E-mailNewsService <biomednews@aol.com>
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Subject: BMN PRESS RELEASE: PDA 2005 Extractables/Leachables Forum, May 23-25 2005
PDA 2005 EXTRACTABLES/LEACHABLES FORUM
-- Keynote Speaker: Moheb N. Nasr PhD, Director, Office of New Drug Chemistry, DCER, FDA
-- May 23-25 2005 -- Bethesda MD
http://sacserv.com/links.jsp?linkid815&subid412705&campid1636&type=0
BETHESDA MD USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- MAY 09 2005 -- This 2-1/2 day forum on May 23-25 focuses on the analytical, material, regulatory and toxicology issues pertaining to container and closure qualification for extractables and leachables. Actionable strategies will be presented for developing the organizational team framework to qualify container/closure systems, drug delivery systems and process material for use with drug and combination products. Additionally, this forum will provide current guidance and capture industry's best practices for conducting qualification studies.
KEYNOTE SPEAKER:
PDA is honored to host Dr. Moheb N. Nasr, as the keynote speaker for this event. He is currently the Director, Office of New Drug Chemistry, CDER, at the FDA.
CONFERENCE HIGHLIGHTS:
The comprehensive agenda for the forum covers the 4 key areas of materials, chemistry, toxicology and regulatory, and is packed with information, including:
-- 6 new case studies
-- 7 Materials presentations stressing the collaborative nature of addressing extractables/leachables issues
-- 4 Chemistry presentations focusing on the latest analytical methods and protocols to detect, identify and quantify extractables
-- 7 presentations providing US, European and Canadian perspectives on Toxicology and Regulatory
-- 4 roundtable discussions providing opportunities to get answers to your specific questions
-- 4 panel discussions
WHEN & WHERE:
The conference will be held May 23-25 at the Marriott Bethesda North, in Bethesda MD.
Please forward this press release to colleagues who may want to read it.
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