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Heparin Workshop (By Invitation Only)

July 27-28, 2009
USP Headquarters, Rockville, Maryland

Overview

This symposium is organized by United States Pharmacopeial Convention, National Institute for Biological Standards and Control and the European Directorate for the Quality of Medicines and HealthCare (Council of Europe).

If you are a scientist, regulator and/or manufacturer who works with heparin either in manufacturing or research and development this workshop is a "must attend" to learn the latest about Heparin monograph revisions, standardization of low molecular weight heparins and characterization of unfractionated heparin.

This workshop is intended to encourage open discussion and debate on the physico-chemical and functional characterization of therapeutic products containing or derived from heparin, and to explore possible clinical and regulatory implications as seen from different view points.

Agenda

Download final agenda  (108KB)

Presentations

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

Day 1:

Bioassay for LMW Heparins
Potency Assignment and Reference Standards
Biosimilars for LMW Heparins
Experiences with Biosimilar LMWH
Physico-Chemical Characterization of LMW Heparins

Day 2:

Replacement of UFH International Standard of Potency
Contamination of Heparin – Progress Report from Licensing Authorities
Physico-Chemical Characterization of UFH
Pharmacopeias – Heparin Monograph Revisions & Global Harmonization
Industry Implementation of the Proposed Heparin Monograph

Contact Information

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