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    RAPS Seeks Four Senior Regulatory Pros to Join Board

    RAPS is seeking four new directors to join its board for the 2021–23 term. The deadline to submit nominations is 27 March. Qualified candidates will be experienced senior regulatory leaders with a strong desire to advance and support the profession and must be RAPS members in good standing. Anyone interested can learn more about the nomination process , review the position descriptions and duties and download the nomination form from RAPS’ website. “Serving on RAP...
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    With EU Medical Device Regulation Deadline Looming, Regulatory Pros to Gather in Brussels for RAPS Euro Convergence

    RAPS will host its annual European conference, newly dubbed Euro Convergence 2020 , in Brussels, 11–13 May, at the Radisson Blu. The event will draw a broad range of professionals and regulators concerned with the regulation of medical devices, medicines and other healthcare products, and take place just two weeks before the planned implementation of the EU’s extensive overhaul of its rules governing devices, the Medical Device Regulation (EU MDR).   While much attent...
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    A Record-High 362 Regulatory Professionals Pass the RAC Exam

    A record-high 362 regulatory professionals have passed the Regulatory Affairs Certification (RAC) exam during the most recent RAC exam period, RAPS announced today. Passing the RAC exam requires essential knowledge of healthcare product regulations, critical thinking and analytical skills. The rigorous exam challenges regulatory professionals not only to know applicable regulations, but also how they apply in various real-world situations. The 362 individuals who p...
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    RAPS 2020 Board Begins Term, Welcomes Trautman, Pokrop and Hoekstra

    The RAPS board of directors of officially began its 2020 term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, is serving his second year as chairman. Boyer’s term was extended from one to two years when the RAPS board officers’ structure was changed by member vote in November. The term of the board president was also increased to two years, and the president-elect position was eliminated. “I am honored to have the...
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    RAPS' Regipedia, a Wiki Built for Regulatory Pros

    One of RAPS’ newest member-exclusive resources may actually be somewhat familiar to you already. RAPS Regipedia is an online compilation of regulatory terms and definitions originally derived from RAPS’ Acronyms & Definitions guides. For nearly two decades, regulatory professionals have been using Acronyms & Definitions guides to look up all manner of terms related to the regulation of drugs, medical devices, biologics and other healthcare products. RAPS published...
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    RAPS Launches Search for New Executive Director

    RAPS’ board of directors announced today that it has initiated a search for its next executive director, following an early retirement request from current executive director Paul Brooks, due to family health concerns. Paul will retire in 2020 after serving in that position for the past three years and will continue in a supporting capacity until a successor is appointed. During the transition period, RAPS COO Bill McMoil will lead RAPS staff and the RAPS executive managem...
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    RAPS Welcomes Colorado Chapter

    RAPS has announced the official launch of the RAPS Colorado Chapter . The group first began as a RAPS-affiliated local networking group before becoming a full chapter. Chapter leaders and other representatives attended RAPS’ recent Regulatory Convergence in Philadelphia, where they were welcomed and acknowledged by RAPS Executive Director Paul Brooks. “We are so pleased to officially welcome the RAPS Colorado Chapter,” said Brooks. “RAPS chapters are a vital part of ou...
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    RAPS Honors Four New Fellows

    RAPS today honored the 2019 class of RAPS Fellows , a distinction bestowed upon seasoned regulatory leaders who have gone above and beyond to give back to the profession and share their experience and expertise with others.   “To be named a RAPS Fellow, an awardee must exhibit unique dedication to the regulatory field that is demonstrated by a history of commitment and success,” said RAPS Chairman Don Boyer, BSc, RAC, FRAP. “From a strategic leader to a dedicated ment...
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    RAPS Honors Winners of Founder’s Award, Community Leadership Award and New Patient-Centered Health Award

    RAPS today recognized five distinguished individuals and one leading advocacy organization for contributions to the regulatory profession and to promoting public health.   “The Founder’s Award is RAPS’ highest honor,” said RAPS Executive Director Paul Brooks. “It recognizes exemplary professionals who have had a substantial and sustained impact over the course of their careers, shaping regulatory policy and practice, and advancing the regulatory profession.”   The ...
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    214 Earn Regulatory Affairs Certification (RAC), Including First Group to Earn Medical-Device- or Drugs-Specific RACs

    RAPS announced today that 214 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, this past spring. Of that group, 59 passed one of two new variations of the RAC exam designed to test knowledge of regulations pertaining to either pharmaceuticals or medical devices, specifically.   The RAC exams cover knowledge of healthcare product regulations, critical thinking and analytical skills that regulatory professionals with thr...
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    13 Keys to a Successful FDA Advisory Committee Meeting

    When the US Food and Drug Administration (FDA) has significant questions or concerns about clinical data submitted in support of a product under review, it often seeks input from independent academicians and clinicians outside the agency. For this reason, FDA has established Advisory Committees comprised of such experts in various therapeutic areas. Currently, there are 49 such standing committees. If your company is a sponsor of a product subject to Advisory Committee rev...
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    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 ...