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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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    Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization

    This article discusses transitioning from medical writing to regulatory affairs within a Contract Research Organization (CRO). Both roles are summarized and the similarities and differences between these two areas discussed. The author highlights why one might want to make the change in either direction and from her own transition experience, offers helpful hints for success. Introduction In the pharmaceutical industry, working in the regulatory field offers many possi...
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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 ...
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    RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book

    RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs , the most extensive regulatory affairs textbook available, covering US regulations for pharmaceuticals, medical devices, biologics and related healthcare products. First published 20 years ago, the book has become an important reference for regulatory professionals and others working with healthcare products regulated by the US Food and Drug Administration (FDA) and other US agen...
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    Canadian Regulator and Regulatory Experts to Speak at 2019 Convergence

    RAPS’ 2019 Regulatory Convergence in Philadelphia will include a session hosted by the Canadian Association of Professionals in Regulatory Affairs (CAPRA). RAPS and CAPRA enjoy a collegial relationship and have collaborated on a number of initiatives in recent years. RAPS is even offering CAPRA members the opportunity to attend this year’s Convergence at the RAPS member rate. This is the second consecutive year CAPRA has hosted a session within RAPS’ signature annua...
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    7 Things Attendees Love About the Regulatory Convergence

    RAPS’ signature annual event, the Regulatory Convergence , is a unique opportunity for the regulatory community to gather, reconnect, examine important issues together and exchange ideas face-to-face in a setting completely dedicated to the profession. It is the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space. For many, it is the one event they prioritize above all others to attend each year. This year...
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    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, ...
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    MDR, IVDR and ‘Navigating the Grey’ Key Topics at RAPS Regulatory Conference Europe Opening

    The RAPS Regulatory Conference Europe 2019 kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. The EU’s transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was a key point of discussion as multiple panelists expressed concern about the ti...