6th Workshop on the Characterization of Heparin Products

Co-sponsored by: USP, ANVISA, NIBSC and Sindusfarma

Symposium Organized by The United States Pharmacopeial Convention (USP), the National Institute for Biological Standards and Control (NIBSC), Agência Nacional de Vigilância Sanitária (ANVISA) and Governo Federal Brasil Patria Educadora.

The 6th Workshop on the Characterization of Heparin Products will encourage open discussions and debate on the potential reintroduction of bovine heparin into the U.S. market and other issues related to the quality of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) products. Since major manufacturers and suppliers of bovine-derived materials are located within Latin America, São Paulo is the ideal location for this workshop.

Since this event will attract a worldwide audience, simultaneous interpretation will be offered in English and Portuguese.


Exhibit Opportunities

A limited number of table top exhibit spaces are available. If your company is interested in exhibiting, non-Brazilian companies should contact USP–U.S. Meeting Services at conferences@usp.org; Brazilian companies should contact Ms. Giuliana Parrilo with USP-Brazil at gmp@usp.org for information. Note: USP does not endorse any product, company, manufacturer, or organization exhibiting in workshop.

Workshop Goal

  • Discuss reintroduction of bovine heparin into US market and its ramifications
  • Enhance understanding of the differences between porcine and bovine heparins
  • Develop a strategy on standard setting for bovine heparin
  • Understand clinical implications of reintroducing bovine heparin
  • Comprehend the risks of bovine spongiform encephalopathy (BSE) associated with bovine heparin


  1. Unfractionated Heparin (UFH): Characterization and Standardization
    1. Bovine UFH Active Pharmaceutical Ingredient (API) sourcing and production
    2. BSE issues, mitigation strategies, and available tests
    3. Species identification tests
    4. Differences between porcine and bovine heparins
    5. USP Heparin Sodium monograph revision updates
    6. Implementation of Stage 3 revisions
  2. Low molecular weight heparins (LMWH)
    1. New pharmacopeial methods, new identification tests, manufacturing process controls, and characterization
    2. Follow-on LMWH products
    3. Impact of UFH quality changes on LWMH products
  3. All Heparin Products
    1. Regulatory and dossier requirements
    2. Novel clinical indications
    3. Synthetic heparins

Who Should Participate

  • Analytical chemists
  • QA/QC analysts
  • R&D scientists, managers
  • Manufacturing scientists, managers
  • Regulatory affairs specialists
  • Contract research organizations
  • Contract manufacturing organizations
  • Other—Packaging manufacturers and suppliers

Workshop Steering Committee

  • Ali Al Hakim, Ph.D., Acting Director of Division of New Drug API in CDER/OPQ, FDA
  • Damian Cairatti, M.S., Acting Director, Global Alliances, USP
  • David Keire, Ph.D. Research Chemist, FDA
  • Elaine Gray, Ph.D., Principal Scientist, NIBSC, UK
  • John Hogwood, Senior Scientist, NIBSC, UK
  • Tina Morris, Ph.D. Vice President, Biologics & Biotechnology, USP
  • Paulo Mourão, Ph.D., Federal University of Rio de Janeiro and Brazilian Pharmacopeia Biotecnology Expert Committee Member
  • Barbara Mulloy, Ph.D., Institute of Pharmaceutical Science King’s College London, UK
  • Monica da Luz Carvalho Soares, Ph.D., Brazilian Pharmacopeia Coordinator
  • Anita Szajek, Ph.D., Scientific Liaison to Unfractionated Heparin Expert Panel, USP

Registration Information

Regular Price Information

Registration fees for this workshop have been set as follows:

General Participant R$ 2,075
Federal / National Government Participant R$ 460
Full-time Student Participant R$ 265

All fees shown in Brazilian Real

Click here to register

(Note! Register using Google Chrome or Firefox internet browsers. Internet Explorer is not compatible with the registration system.)

Other Registration Information

Registration fee includes full two-day program, meeting materials, coffee breaks, and a networking reception. Contact conferences@usp.org for registration questions.

Sheraton Saõ Paulo WTC Hotel
Avenida das Nações Unidas, 12559 - Brooklin Novo
Sao Paulo 04578-903
Phone: +1-301-881-0666
See map: Google Maps