Fierce Drug Safety Week 2021 has ended
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Rachel Bonfanti

Director, Risk Management and Scientific Consulting
Ms. Bonfanti collaborates with UBC safety scientists and operational teams in  risk management consulting (including Risk Evaluation and Mitigation Strategy (REMS) contingency planning), is part of the REMS Assessment Team, and oversees the project management office (PMO) services for shared system (SS) REMS programs. Ms. Bonfanti has been with UBC for over 10 years and has worked on the design, operations, and/or assessment of over 30 REMS that include Elements to Assure Safe Use (ETASU).
As Director of Risk Management and Scientific Consulting, she develops strategy and creates REMS, REMS Supporting Documents, REMS tools, and REMS Assessment Reports, including the facilitation of graphic layout. She supports sponsors in the preparation for and participation in FDA Advisory Committee meetings and other regulatory meetings and drafts regulatory communications regarding REMS. Ms. Bonfanti leads the team responsible for PMO services and has experience working on multiple SS REMS ranging from 3 sponsors to over 80 sponsors

My Speakers Sessions

Tuesday, January 19

10:05am EST