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    Sandra Kweder

    Senior medical professional and regulatory expert

    Sandra Kweder, M.D. is a Principal, Drug and Biological Products at ELIQUENT Life Sciences (formerly Greenleaf Health), bringing over 30 years of experience in U.S. and international medical products regulation and policy.13

    Key points about Dr. Kweder's background:

    FDA Career

    • Served at the FDA for over 30 years in various leadership roles3
    • Former Deputy Director of the FDA's Center for Drug Evaluation and Research (CDER) Office of New Drugs1
    • Former Deputy Director of the FDA's Europe Office and Liaison to the European Medicines Agency (EMA)1
    • Joined FDA in 1988 as a medical officer in the Division of Antiviral Drug Products1

    Expertise

    • Internal medicine expert3
    • Extensive experience in drug development, regulatory affairs, and public health1
    • Guided CDER's Office of New Drugs through significant growth and modernization from 2002 to 20161
    • Led FDA's modernization of labeling and studying medicines in pregnancy and lactation1

    Current Role

    Dr. Kweder joined ELIQUENT Life Sciences (formerly Greenleaf Health) in early 2023 as Principal, Drug and Biological Products.5 In this role, she offers broad expertise in FDA regulatory processes, drug development strategies, and international regulatory collaboration.12

    Education

    Dr. Kweder received her education from Brown University.4

    Her LinkedIn profile can be found under the username sandra-kweder-2b334912.45

    Highlights

    Mar 25 · cellandgene.com
    Reducing The Number Of Clinical Holds On Cell And Gene Therapies
    FORMER FDA SENIOR OFFICIALS JOIN GREENLEAF HEALTH
    Dec 15 · govinfo.gov
    [PDF] prescription drug shortages: examining a public health concern and ...

    Related Questions

    What are some of the key achievements of Sandra Kweder during her time at the FDA?
    How did Sandra Kweder's role at the FDA's Europe Office impact international drug regulations?
    What specific projects did Sandra Kweder lead at the FDA regarding drug labeling and pregnancy studies?
    How has Sandra Kweder's experience in the U.S. Public Health Service influenced her regulatory approach?
    What are the main challenges Sandra Kweder has faced in her career at the FDA and how did she address them?
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    Location

    Silver Spring, Maryland, United States