Symposium on Medicines Quality Highlights US Pharmacopeial Convention's Commitment to Global Partnerships
São Paulo Meeting Co-Sponsored by ANVISA, Brazilian Pharmacopoeia and Other Regional Stakeholders
SÃO PAULO, Brazil, July 29, 2013 /PRNewswire-USNewswire/ -- The United States Pharmacopeial Convention (USP) hosted the 2nd Annual USP-Brazil Science & Standards Symposium in São Paulo, "Partnering Globally for 21st Century Medicines," on July 25-26. Attended by 400 regulators, academicians, pharmaceutical manufacturers and quality assurance and control experts from Brazil and other Latin American countries as well as the U.S., the meeting focused on quality standards for chemical and biological medicines as well as globalized approaches to developing quality standards.
Co-sponsors of the meeting were Brazil's National Health Surveillance Agency (ANVISA)/Brazilian Pharmacopoeia, the University of São Paulo School of Pharmaceutical Sciences, the São Paulo Pharmacy Council, the Federal University of Minas Gerais School of Pharmacy, the Foundation for Popular Medicines and the National Academy of Pharmacy.
The meeting marked the first time that ANVISA has co-sponsored a USP scientific meeting in Brazil, underscoring the importance of multi-national relationships among health organizations.
"It is critical for organizations that support global health—manufacturers, regulators and pharmacopoeial groups alike—to maintain an ongoing dialogue on best approaches for establishing and harmonizing standards for medicines that help safeguard health regionally and throughout the world," said Roger L. Williams, M.D., chief executive officer of USP. "As the global industry and medicines themselves become more complex, we need standards to help ensure that the quality of all medicines is well protected."
According to Mônica Soares, Ph D., Brazilian Pharmacopoeia coordinator at ANVISA, "Meetings like the Science & Standards Symposium and partnerships with organizations such as USP give those of us responsible for protecting the supply of medicines in Brazil and other Latin American countries a chance to learn from one another about the challenges we share and generate solutions for addressing those challenges."
Emphasizing global partnerships for standards development and harmonization, presentations addressed topics such as:
- Using a comprehensive monograph and more modern understanding of in vitro dissolution to reduce regulatory burden
- Quality determination of modern biologic medicines including monoclonal antibodies, heparin, and tumor necrosis factor
- New approaches for developing global public quality standards, such as the Medicines Compendium, working in partnership with all national pharmacopoeias
- USP standards for impurities in medicinal ingredients and products
- Standards for first and subsequent entry non-interchangeable biologics, biosimilars, and interchangeable biosimilar medicines.
Prior to the start of the symposium, a ribbon-cutting ceremony marked the recent expansion of USP-Brazil's laboratory site in São Paulo. Established in 2008, USP-Brazil is one of USP's four global laboratory facilities, which also include Shanghai, China; Hyderabad, India and Rockville, Md. (U.S. headquarters). The expansion at USP-Brazil will increase the organization's capabilities to update and modernize standards appearing in U.S. Pharmacopeia and the National Formulary (USP–NF), USP's compendia of quality standards for medicines manufactured or marketed in the U.S. USP-Brazil also is developing standards for the Medicines Compendium, USP's all online, freely available compendium for medicines marketed in any country. USP's standards are used by manufacturers, regulators and other pharmacopoeias around the world.
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The U.S. Pharmacopeial Convention (USP) is a nonprofit scientific organization that improves global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are used worldwide. For more information about USP visit http://www.usp.org.
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SOURCE U.S. Pharmacopeial Convention