IPEC-Americas has published the first revision of their U.S. Drug Master File Guide for Pharmaceutical Excipients. The revised voluntary guide offers best practices related to submission of an excipient drug master file utilizing the ICH Common Technical Document (CTD) format. The session will cover the guide's revisions and updated material.
- Reason(s) for excipient DMF
- Content and level of information for excipient DMF (based on excipient type)
- Regulatory requirements, if any, that apply
- Process for filing a U.S. excipient DMF
- Electronic filing requirements
- IPEC’s collaboration with FDA
- Excipient dossier requirements in other regions (China, Japan, Canada)
Katherine Ulman retired from Dow Corning Corporation, now a wholly owned subsidiary of The Dow Chemical Company, after more than 40 years of employment. There she held positions as a global regulatory compliance manager for their healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site.
Meera Raghuram is currently the Director, Regulatory Strategy and Policy for the Life Sciences Division of the Lubrizol Corporation. She has over 20 years of experience in complex technical and strategic regulatory issues related to pharmaceutical excipients, drugs/devices, environmental impact, risk assessments and liability management.
She is a member of IPEC-Americas Executive Committee and serves as the Chair of the IPEC-Americas Regulatory Affairs Committee.
She has also been involved in advocacy and leadership on critical environmental issues with various industry organizations including the American Chemistry Council and ASTM. Meera has a B.S degree in Pharmacy from the Indian Institute of Technology and a M.S. in Pharmaceutical Sciences from Purdue University, IN.