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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...
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    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...
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    European and UK Health Authority Officials, Industry Leaders, Notified Body Reps, Other Experts to Speak at RAPS’ Europe Conference

    RAPS released the updated agenda for its upcoming European conference in Brussels, 13–14 May. Among the speakers for the inaugural RAPS Regulatory Conference – Europe 2019 are representatives from the European authorities, notified bodies and trade representatives, all thought leaders and stakeholders with crucial responsibilities in the effective implementation and functioning of the changing European regulatory environment. “Europe’s regulatory environment for med...
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    How I Returned to Regulatory Affairs After a 10-Year Break

    The decision whether or not to take a career break can be an agonizing one. You might be thinking about stepping away to raise a family, care for an ailing relative, take a sabbatical, because of redundancy or for a number of other reasons. Whatever the reason, many consider it to be professional suicide. It doesn’t have to be. I was able to make a successful return to the world of regulatory affairs after a 10-year career break. That’s not to say it’s easy. There are m...
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    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...