USP Workshop—Compendial Nomenclature: Overview and Challenges

This was USP's first ever forum for discussion of current policy issues regarding U.S. and international compendial nomenclature was. The workshop was pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Topics:

  • Drug substance and drug product nomenclature
  • Workplan of the 2010–2015 USP Nomenclature, Safety, and Labeling Expert Committee
    and the proposed concept of a nomenclature guideline
  • Current and emerging nomenclature initiatives of the USP, FDA, other pharmacopeias,
    and international bodies
  • Implementation and communication issues related to the USP Monograph Naming Policy
    for Salt Drug Substances in Drug Products and Compounded Preparations
  • Naming challenges in the areas of biologics, excipients, dietary supplements, and
    food ingredients

When: July 27–28, 2010

Where: USP Headquarters; Rockville, MD, USA

Agenda

Presentations:

Participants:

  • Domestic and international regulators
  • Pharmaceutical industry professionals (innovator/generic)
  • Pharmaceutical industry associations
  • Regulatory affairs and quality control professionals
  • Nomenclature experts