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USP Stakeholder Forums

Prescription/Non-Prescription Stakeholder Forum

Meet 7: May 15, 2008 - Spalding Auditorium, USP Headquarters, Rockville, Maryland

• Agenda  (56KB)
• Discussion Notes and Action Items  (121KB)
• Attendee List  (56KB)
• Attendees Presentations

1. Opening, Welcome and Call to Order SGM/USP Updates PDG/Q4B – Portland Meeting	Roger Williams, M.D., Darrell Abernethy, M.D., Ph.D.   (234KB)
2. Prospective Harmonization (Unified Pharmacopeia): Status	Mark Wiggins, Roger Williams, M.D.  (328KB)
3. Project Team Updates Reports from PT Chairs March 28 Meeting	Roger Williams, M.D., Project Team Chairs, Phil Travis  (297KB)
4. General Notices PT Discussion	Neil Schwarzwalder  (70KB)
5. Microbiology Chapter Implementation Discussion Panel (FDA, USP, Industry-NJPQCA speaker)	Barbara Ferguson, Radhakrishna Tirumalai, Ph.D., Panel Discussion  (229KB)
6. FDA/USP Collaboration Heparin, Glycerin Residual Solvents—FDA Q&A	Ali Al-Hakim, Ph.D., Darrell Abernethy, M.D., Ph.D., William Koch, Ph.D., Larry Ouderkirk  (664KB)
7. Pending Standards	Roger Williams, M.D., Susan de Mars, J.D.  (197KB)
8. Council of the Convention-Update	Barbara Ferguson, Gordon Johnston, Frederick Razzaghi  (197KB)
9. Status Reports/Hot Topics European SF/EDQM Meeting Monograph Redesign Dissolution PVT Update	Angela Long, Todd Cecil, Ph.D., Anthony DeStefano, Ph.D.  (281KB)