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  • RAPS' LatestRAPS' Latest

    Focus on: Linda Bowen

    Linda Bowen has more than 35 years of experience in the pharmaceutical industry, including 25 in regulatory and the last 12 specifically focusing on regulatory policy and intelligence. She has been an active volunteer with RAPS at both the global and local levels, having served on RAPS’ board of directors, as a chapter chair, and as an expert author, presenter and speaker. She is currently the chair of the planning committee for the 2019 Regulatory Convergence . Linda is ...
  • RAPS' LatestRAPS' Latest

    Focus on: Allison Komiyama

    Allison Komiyama began her regulatory career at the US Food and Drug Administration (FDA) as a biologist and reviewer, and served as lead reviewer and consult on 510(k) premarket notifications, investigational device exemption (IDE) applications and premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. After FDA, Allison worked on the industry side in senior regulatory roles before starting her own consulting firm, ...
  • RAPS' LatestRAPS' Latest

    Focus on: Bill Sietsema

    Bill Sietsema has 35 years of experience in the pharmaceutical industry and is currently vice president of global regulatory affairs at Caladrius Biosciences. He has also held executive-level regulatory positions with Amgen, Kendle International/INC Research and has taught pharmaceutical sciences at the University of Cincinnati, College of Pharmacy as an adjunct professor. He has authored 24 journal articles, four book chapters, 42 presentations and posters and is an inven...
  • RAPS' LatestRAPS' Latest

    Focus on: Minnie Baylor-Henry

    Minnie Baylor-Henry has served two separate stints as one of Johnson & Johnson’s top executives, most recently as worldwide vice president for regulatory affairs for J&J’s medical devices and diagnostics business, overseeing global regulatory strategy for numerous products. She also has been with Deloitte & Touche as a national director for regulatory and capital markets consulting, and with the US Food and Drug Administration (FDA) in roles including national health fraud...
  • RAPS' LatestRAPS' Latest

    Focus on: Jethro Ekuta

    Jethro Ekuta, DVM, RAC, FRAPS, is the senior vice president for regulatory, safety and standards at Horizon Pharma. He has more than 21 years of experience in pharmaceutical research and development, and has served in a number of leadership positions with Johnson & Johnson, Genzyme, Bristol-Myers Squibb and others. He also is an active RAPS volunteer leader, having served in roles including chair of the RAPS Fellows Selection Committee and as a member of the Regulatory Aff...
  • RAPS' LatestRAPS' Latest

    Focus on: Don Boyer

    Don Boyer spent more than 30 years at Health Canada, including serving in several senior management positions, before leaving Canada’s regulator to start his own regulatory consulting firm. Earlier this month, he began his term as chairman of the RAPS board of directors. Don is a leader in the global regulatory community, and has been active not only with RAPS, but also with organizations such as the Global Harmonization Task Force and International Medical Device Regulat...
  • RAPS' LatestRAPS' Latest

    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...
  • RAPS' LatestRAPS' Latest

    Focus on: Susumu Nozawa

    Susumu Nozawa, RAC (US and EU), FRAPS, is the current chair of RAPS’ board of directors. He has more than 15 years of experience in US and international regulatory affairs and compliance, most recently as director of technical and regulatory policy and corporate regulatory affairs at BD in Franklin Lakes, NJ. He also is an active volunteer leader with RAPS as well as other professional organizations, including AdvaMed and the American Medical Devices and Diagnostics Manuf...
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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...
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    RAPS Seeks Board Nominations

    RAPS has begun the nomination process for openings for the 2018–2020 term of its board of directors , and is now accepting nominations for president-elect and up to four director positions. Nominees must be active RAPS members in good standing, and all completed nominations applications and supporting materials are due 31 March . For more information visit: Board of Directors Nomination Process . At least two letters in support of the nomination should be ema...
  • Regulatory NewsRegulatory News

    NIH, FDA Release Streamlined Clinical Trial Protocol Template

    In an effort to increase the efficiency of clinical trial protocol reviews, the National Institutes of Health (NIH) has released a draft protocol template developed in collaboration with the US Food and Drug Administration (FDA). The draft protocol, developed by the NIH-FDA Joint Leadership Council (JLC), will apply to NIH-funded Phase II and III clinical trials done in support of an investigational new drug application (IND) or investigational device exemption (IDE). T...
  • Regulatory NewsRegulatory News

    FDA, NIH Unveil Glossary of Clinical Definitions

    A joint US Food and Drug Administration (FDA), National Institutes of Health (NIH) Leadership Council has released a glossary of definitions, meant to clarify and describe some of the relationships, connections and distinctions among terms used in translational science and medical product development. The council’s development of the glossary is part of the first phase of its BEST (Biomarkers, Endpoints, and other Tools) Resource and aims to capture differences between b...