Heparin Workshop

July 27, 2009 - July 28, 2009

Overview

Overview: 

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.

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

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
Who Should Participate: 

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

Agenda

application/pdf iconAgenda

Registration Information

Other Registration Information: 

Registration is now closed.

USP Headquarters
20852
美国
Phone: 1-301-881-0666
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