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Catherine Sheehan, PhD


Sr. Director, Excipients


Ms. Sheehan is currently the Senior Director of Science – Excipients at the United States Pharmacopeia (USP), Rockville, MD. In her current role, she co-leads the Excipients Program Unit, responsible for Science related activities through the development of global quality excipient standards and related programs, outreaching to stakeholders, partnering to improve awareness and advocating for adoption of new and up-to-date excipient quality standards and related programs. Responsibilities include excipient standard setting activities supporting the USP Council of Experts, two Excipient Monograph Expert Committees and General Chapters Expert Committees responsible for development and update of high priority excipient monographs and related general chapters as part of USPs Up-To-Date initiative. Her current responsibilities also include support of the Pharmacopeial Discussion Group (PDG) comprising the USP, European Pharmacopoeia and Japanese Pharmacopeia to successfully complete harmonization of the revised list of excipient monographs and excipient related chapters undergoing harmonization through PDG. She also supports other USP’s collaborative efforts with pharmacopeial bodies outside PDG such as bi lateral harmonization of excipient monographs. Ms. Sheehan is active in AAPS and RAPS.

Ms. Sheehan holds both an M.S. Regulatory Science degree and M.S. Molecular Biotechnology degree from The Johns Hopkins University, Baltimore, USA.


The Value of Setting Meaningful Compendial Specifications for Excipients – a USP Perspective 05/07/2019 09:30 AM An Update for Novel Excipients from IQ Consortium, USP and IPEC-Americas 05/07/2019 4:15 PM
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