Meeting #1 - June 7, 2013

Excipients

The United States Pharmacopeial Convention (USP) will be holding the first Excipients Stakeholder Forum on June 7, 2013 at USP–U.S. in Rockville, Maryland, USA. To expand the opportunity for stakeholder participation, USP will offer a web-based component for those who would like to attend the meeting remotely. Registration is free for both in person and remote attendance.

The USP Excipients Stakeholder Forum has been created to enable an exchange of information and perspectives between USP and users of USP standards, with the ultimate goal of improving USP standards. The Excipients Stakeholder Forum will provide an opportunity for manufacturers, distributors, and users of excipients to discuss topics in an open forum setting. USP hopes the forum will encourage excipients constituencies to work openly and directly with USP as well as collaborate with fellow stakeholders.

Discussion at the Stakeholder Forum will be focused on science and compliance topics specific to pharmaceutical excipients:

  • Introduction to USP and its public standards-setting process
  • Modernization of existing National Formulary excipient monographs
  • USP’s role in excipient GMPs
  • Update on implementation of elemental impurities General Chapters <232> and <233>

Objectives

  • Extending opportunities for participation to a broad range of excipients stakeholders to ensure industry-wide input to USP
  • Educating stakeholders on USP activities while helping USP staff understand excipients issues
  • Providing information on emerging USP initiatives that might affect excipients stakeholders

Who Should Participate

Manufacturers, suppliers, and users of excipients, whether members of a trade organization or independent.

Agenda

Venue

Classroom
USP–U.S.

Contact Information

Jessica Simpson
jcs@usp.org

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Outcomes