The session will provide an overview of the recently published DMF Guide.
REGISTRATION will be open soon!
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.
Katherine Ulman recently 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. She is currently an active member and vice chair of the Regulatory Committee for IPEC-Americas as well as a member of their executive committee. Ulman earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology.
Meera Raghuram is currently the Director, Regulatory Strategy and Policy for the Personal, Home and Health Care Division of Lubrizol Corporation. She has over 20 years of experience working in varied regulatory areas. She serves as the Chair of the IPEC Regulatory Affairs Committee and has been involved with various industry organizations including the American Chemistry Council and ASTM. Meera has a B.S degree from the Indian Institute of Technology and a M.S. in Pharmaceutical Sciences from Purdue University, IN.