Eva Marie Schifini
Associate Global Regulatory
Languages
English
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Overview
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Experience
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Credentials
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Insights and events
Eva Marie Schifini advises pharmaceutical and biotechnology companies throughout the product life-cycle on how to navigate the regulatory landscape, ensure compliance, and develop related contractual relationships.
Eva regularly counsels on issues related to clinical trial development, advertising and promotion, state licensure, and lifecycle management. Further, she assists clients in evaluating and addressing regulatory issues related to strategic transactions and partnerships involving life sciences companies.
While attending USC Gould School of Law, she was a research assistant to a thought leader in drug economics and policy at the USC Leonard D. Schaeffer Center for Health Policy & Economics.
Representative experience
Draft innovator responses to proposed regulations and guidances (including Product-Specific Guidances for Generic Drug Development) and citizen petitions seeking therapeutic equivalence ratings
Counsel manufacturers on unique issues related to the development and commercialization of controlled substances
Advise pharmaceutical companies on pre-approval and post-market promotional issues, including experience on promotional review committees
Support clinical trial development (including contractual and regulatory matters) and forming expanded access programs
Credentials
- J.D., University of Southern California Gould School of Law, Gold Honors Scholar, Chair, Hale Moot Court Honors Program, 2020
- B.A., Occidental College, Honors in Economics, magna cum laude, 2017
- California
- U.S. Court of Appeals, Fifth Circuit