Lisa Butler, 2016 PDMA Alliance President
Lisa A. Butler, newly elected president of the PDMA Alliance, has been an Alliance Board Member for the past three years. She is an associate director of DEA/PDMA Compliance for Novartis Business Services. For the last 25 years, she has held various positions in the pharmaceutical industry and has worked within her current area of responsibility for the last 15. Lisa’s areas of expertise include: DEA Controlled Substance compliance, PDMA Sample Compliance and State and Federal commercial distribution licensing for pharmaceutical products.
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Lisa takes over from Don DeSmet, Alliance President for the past three years. He has served on the Alliance Board for 12 years. During this time, Don’s steadfast leadership, dedication and his ability to bring people together have been an inspiration to his colleagues. Working at Bayer Healthcare for 15 years, Don is now Manager of Sample Accountability, responsible for PDMA compliance, as well as Vendor Partner Management for Sample Accountability and Bayer’s Sample Send program. Previously, Don spent 25 years in various senior logistics and warehouse operations positions for both pharma and consumer goods organizations.
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Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.