Currently the Senior Director of Science – Excipients at the United States Pharmacopeial Convention, Dr. Sheehan co-leads the Excipients Program Unit. Responsibilities include, excipient standard setting activities supporting the USP Council of Experts, Excipient Monograph Expert Committees and the General Chapters Expert Committees for development and modernization of high priority excipient monographs and related general chapters as part of USPs Up-To-Date initiative. She currently leads the USP delegation to the Pharmacopeial Discussion Group’s compendial harmonization of excipient monographs and general chapters in partnership with the European Pharmacopoeia and Japanese Pharmacopeia. She also works in collaboration with other pharmacopeial organizations worldwide to harmonize excipient monograph specifications and participates in WHO’s International Meeting of World Pharmacopoeias who recently developed the Good Pharmacopeial Practices guidelines for use by all 194 WHO member states. Dr. Sheehan is active in AAPS and RAPS.
Dr. Sheehan earned her Ph.D. in International Regulatory Science from the USC School of Pharmacy. She also holds both an M.S. Regulatory Science degree and M.S. Molecular Biotechnology degree from The Johns Hopkins University, Baltimore, USA.
(Disclaimer: The article below includes a discussion of key points of the guidance document.
With significant innovations in pharmaceuticals, including biologic drugs
