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  • RAPS' LatestRAPS' Latest

    John Lim, Justina Molzon, Barbara Schneeman and Mike Ward to Receive RAPS’ Highest Honor

    RAPS has announced the recipients of its 2018 Founder’s Award. They are: John Lim, MD, executive director, Center of Regulatory Excellence, Singapore; Justina Molzon, JD, former associate center director for international programs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA); Barbara Schneeman, PhD, former director, Office of Nutrition, Labeling and Dietary Supplements, FDA; and Mike Ward, coordinator, Regulatory System Strengthen...
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    RAPS to Honor Lena Cordie, Alan McEmber for Outstanding Community Leadership

    RAPS has announced the recipients of its 2018 Community Leadership Award. They are: Lena Cordie, president, Qualitas Professional Services, and Alan McEmber, MS, RAC, head, therapeutic area regulatory strategy, Shire. The Community Leadership Award recognizes RAPS members who have helped build thriving local networks, supported fellow regulatory professionals and acted as RAPS ambassadors. Cordie and McEmber will be honored and receive their awards next week during RAP...
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    RAPS Honors Regulatory Leaders With Two New Awards

    RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference, being held at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September . Four outstanding individuals who have had a profound impact on the regulatory profession during their careers will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees...
  • FDA to Spend up to $10 Million Strengthening Regulation in South America

    • 17 July 2014
    US regulators are planning to work more closely with a global health group focused heavily on South America in the hopes of strengthening medical product regulatory systems across the region. In an announcement on 8 July 2013, the US Food and Drug Administration (FDA) said it plans to award the Pan American Health Organization (PAHO) a contract to help "foster regulatory collaboration and strengthen regulatory capacity throughout the Americas." Regulatory capacity broad...
  • IBM Awarded Huge Contract to Modernize Regulatory Review Processes at FDA

    The US Food and Drug Administration (FDA) has awarded a massive new contract to contractor International Business Machines (IBM) to help the agency improve its ability to review and analyze regulatory submissions the agency receives from pharmaceutical, medical device and biologic manufacturers. Background FDA first published a request for a proposal in July 2012, explaining that it was "seeking strategic and operational planning and other technical and user support, ...
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    Outstanding Contributions Deserve Outstanding Recognition

    Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds. The RAPS Awards Committee is currently seeking nominations for RAPS' annual awards honoring outstanding regulatory professionals in the healthcare products sector. RAPS' awards programs provide an important opportunity to acknowledge outstanding individual contributors to the regulatory field. This year, the committee has made significant improvements to the...