USP Workshop—Heparin Workshop

Organized by USP, National Institute for Biological Standards and Control, and the European Directorate for the Quality of Medicines and HealthCare (Council of Europe), this "attendance by invitation only" event generated open discussion and debate on the physico–chemical and functional characterization of therapeutic products containing or derived from heparin. Participants also discussed possible clinical and regulatory implications as seen from different viewpoints.

Topics:

• Bioassay for LMW heparins
• Potency assignment and reference standards
• Biosimilars for LMW heparins
• Experiences with biosimilar LMWH
• Physico-chemical characterization of LMW heparins
• Replacement of UFH international standard of potency
• Contamination of heparin—progress report from licensing authorities
• Physico-chemical characterization of UFH
• Pharmacopeias—heparin monograph revisions and global harmonization
• Industry implementation of the proposed heparin monograph

When: July 27–28, 2009

Where: USP Headquarters; Rockville, MD, USA

Agenda

Presentations:
Presentations not included here have not received presenter’s permission to reproduce.

• Day 1
  • Bioassay for LMW Heparins
    • E. Gray, NIBSC
  • Potency Assignment and Reference Standards
    • P. Anger, Sanofi-Aventis
    • P. Carrasco, Rovi, S.A.
    • R. Lecky, LEO Pharma
  • Biosimilars for LMW Heparins
    • E. Gray, NIBSC
    • G. Woollett, Engel & Novitt
  • Experiences with Biosimilar LMWH
    • L. Li, Shenzhen Hepalink
    • J. Walenga, Loyola University
  • Physico-Chemical Characterization of LMW Heparins
    • P. Jongen, RIVM
    • McEwen, MPA
    • C. Viskov, Co-Chair, Heparin Advisory Panel
• Day 2
  • Replacement of UFH International Standard of Potency
    • E. Gray, NIBSC
    • J. Harenberg, Ruprecht-Karls University Heidelberg
  • Contamination of Heparin—Progress Report from Licensing Authorities
    • A Al-Hakim, FDA
    • S. Uzu, Minister’s Secretariat
  • Physico-Chemical Characterization of UFH
    • P. Anger, Sanofi-Aventis
    • T. Wielgos, Baxter
    • McEwen, MPA
    • B. Mulloy, NIBSC
  • Pharmacopeias—Heparin Monograph Revisions & Global Harmonization
    • Szajek, USP
    • N. Kawasaki, JP
  • Industry Implementation of the Proposed Heparin Monograph
    • E. Kellenbach, Schering-Plough
    • E. Moore, Baxter
    • Viskov, Co-Chair, Heparin Advisory Panel
    • K. Johansen, Member, Heparin Advisory Panel and P. Jongen, RIVM

Participants: Scientists, regulators and/or manufacturers who work with heparin either in manufacturing or research and development.