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USP Stakeholder Forums

Prescription/Non-Prescription Stakeholder Forum

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


1. Opening, Welcome and Call to Order
  1. SGM/USP Updates
  2. 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
  1. Heparin, Glycerin
  2. 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
  1. European SF/EDQM Meeting
  2. Monograph Redesign
  3. Dissolution PVT Update
 Angela Long, Todd Cecil, Ph.D., Anthony DeStefano, Ph.D.  (281KB)