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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...
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    RAPS Launches Europe Conference as European Regulatory Environment for Medical Products Faces Sweeping Changes

    RAPS will hold its inaugural RAPS Regulatory Conference – Europe 2019 in Brussels, 13–14 May. It comes as the European regulatory environment for medicines, medical devices and in vitro diagnostics (IVDs) is undergoing major changes, and both regulators and the regulated companies making life-saving and life-sustaining medical products face myriad uncertainties. The EU’s new Medical Device Regulation (MDR) is set to take effect next year. A new In Vitro Diagnostic Re...
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    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...
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    RAPS Opens Board of Directors Nominations

    Today, RAPS opened the call for nominations for three vacant positions on the 2020–22 term of its board of directors. RAPS is seeking qualified candidates to fill the roles of president-elect, treasurer and one director position. Nominations will be accepted now through 29 March. Nominees should be distinguished and experienced regulatory leaders with a strong desire to play an active role in advancing and supporting the profession. To be considered, candidates must be R...
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    235 Earn Regulatory Affairs Certification (RAC)

    A total of 235 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, RAPS announced today. The challenging RAC exams test essential knowledge of healthcare product regulations, critical thinking and analytical skills. To pass, exam takers must be able to demonstrate not only that they know the relevant regulations, but also how they apply in a variety of realistic scenarios. By passing, each of the 235 professionals now hold ...
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    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...
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    RAPS 2019 Board of Directors Begins Term; Don Boyer Takes Helm as Chair

    RAPS welcomed its 2019 board of directors, which officially began its term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, takes over as chairman.   “I am honored to serve as chairman of the RAPS board of directors,” said Boyer. “Throughout its history, RAPS has been instrumental in not only helping regulatory professionals do their jobs better, but also in driving awareness of the critical role the regulatory pr...
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    RAPS Welcomes Utah Chapter

    Just over a year after a RAPS-affiliated local networking group was successfully established in Utah, the group officially became the RAPS Utah Chapter. Chapter Chair Robert Wolfarth, senior manager of regulatory affairs for Merit Medical Systems Inc., shared the news and gave a brief overview of the chapter’s vision and mission on 1 November at the Utah Life Sciences Summit in Salt Lake City, an annual industry event organized by BioUtah, a statewide association of lif...