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    What you need to know about taking the RAC exam online

    Traditionally, candidates for Regulatory Affairs Certification (RAC) have taken their RAC exams in person at one of more than 1,000 authorized testing centers around the world. But when the COVID-19 global health crisis forced most centers to close temporarily in the spring of 2020, RAPS launched a pilot program allowing exam-takers to sit for the exam remotely online. RAPS worked with its testing vendor, Scantron, to roll out a form of test administration called ‘l...
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    Updated Regulatory Writing Book Now Available

    It isn’t easy to be a highly effective regulatory writer, but clear, well-written documentation is a critical part of bringing essential medicines and medical products to market. In RAPS’ newly released, Regulatory Writing: An Overview, Second Edition , aspiring and experienced writers alike will find expert guidance and advice that is easy to apply. Completely updated from the previous edition, Regulatory Writing covers content development for regulatory documents...
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    180 Passed RAC Exams This Summer

    RAPS announced today that 180 regulatory professionals passed the Regulatory Affairs Certification (RAC) exam during the summer 2020 exam period. Passing the RAC exam requires knowledge of, and competency in applying, healthcare product regulations.   There are two versions of the exam—RAC Drugs and RAC Devices—covering regulations for pharmaceuticals and medical devices, respectively. Of the 180 passers, 71 passed the RAC Drugs, and 110 passed the RAC Devices. One p...
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    RAPS' virtual Euro Convergence 'provides needed forum' for European regulatory pros

    RAPS’ weeklong 2020 Euro Convergence wrapped up today, fittingly concluding with a session devoted to the impact of the COVID-19 pandemic on the future of regulatory. The profound effects of the pandemic have reached across myriad aspects of healthcare and regulation, forcing regulators and regulated industry to adapt and collaborate in new ways, streamline processes and work on accelerated timeframes.   Euro Convergence programming also had to adapt to suit this yea...
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    EC’s Erik Hansson among panelists for Euro Convergence opening plenary

    Erik Hansson, the European Commission’s deputy head of devices, will be among the expert panelists kicking off RAPS’ 2020 Euro Convergence , being held live online, 26–30 October. The 26 October plenary, Global Perspectives on the 2020 Regulatory Landscape, will feature 16 regulatory experts from organizations including government agencies, notified bodies and manufacturers. Hansson leads the EC’s operational team dealing with the implementation of the EU Medical Devic...
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    Regulatory professionals’ average compensation continues to increase, according to RAPS’ 2020 compensation survey

    RAPS today released the results of its biennial global survey of regulatory professionals working in the healthcare products sector. RAPS’ 2020 Global Compensation & Scope of Practice Report for the Regulatory Profession provides a detailed look at how much regulatory professionals earn, who they are, and what their work entails. The comprehensive survey collected salary and demographic data for nearly 2,000 respondents from around the world. The average total compens...
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    RAPS Euro Convergence to address Europe’s top regulatory challenges, say conference co-chairs

    RAPS’ 2020 Euro Convergence kicks off in less than three weeks. The conference, which had originally been scheduled to take place in Brussels in May, will be held all online, 26–30 October. It follows the successful, first-ever virtual RAPS Convergence last month, and comes at a crucial time for the life sciences sector in Europe. Even before the COVID-19 pandemic, regulatory professionals working with products for the European market had their hands full. The pendi...
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    RAPS’ updated book on regulatory strategy for devices serves as ‘how to’ guide

    Constant innovation in medical technology, globalization, pressure on medical device makers to control costs and demonstrate clear benefits to patients, and increased scrutiny from regulators make having a sound regulatory strategy more critical than ever. The recently released second edition of RAPS’ Global Medical Device Regulatory Strategy book provides a “how to" guide to developing a comprehensive regulatory strategy for bringing all types of devices to the global...
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    RAPS welcomes new Ontario Chapter

    RAPS has announced the official launch of the RAPS Ontario Chapter , which first began as a RAPS-affiliated local networking group. Ontario joins Vancouver as the second RAPS chapter in Canada and expands RAPS’ global network to now include 20 chapters and eight local networking groups. “We are very excited about the formal launch of our chapter in the RAPS regulatory community,” said founding member and Ontario chapter chair, Ntsakisi Onibayo, RAC, regulatory complian...
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    First virtual RAPS Convergence draws nearly 1,500 participants, earns praise

    RAPS last week wrapped up its first RAPS Convergence conference to be held completely online. RAPS Convergence is the largest annual gathering of the global healthcare regulatory community and the only US event exclusively dedicated to the regulatory profession. RAPS completely redesigned this year’s conference, transforming what has traditionally been a face-to-face event in a different host city each year, into a live, virtual, interactive experience for the nearly ...
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    RAPS recognizes new Fellows, Creaven-Capasso, Drago and McKeen

    RAPS has announced the three outstanding senior regulatory professionals comprising the 2020 class of RAPS Fellows . The honor of being a RAPS Fellow is reserved for seasoned, proven leaders, who thrive on building and sharing regulatory knowledge that shapes the future of the profession. New Fellows are selected annually and recognized in conjunction with RAPS Convergence , the largest annual conference for the global healthcare regulatory community. This year’s event w...
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    RAPS Announces 2020 Founder’s Award, Community Leadership Award and Patient-Centered Health Award Honorees

    RAPS has announced six distinguished professionals and two influential organizations as this year’s honorees of RAPS’ awards for contributions to the regulatory profession and to promoting public health. RAPS’ Founder’s Award, Community Leadership Award and Patient-Centered Health Award are bestowed annually in conjunction with RAPS Convergence , the largest annual conference for the global healthcare regulatory community. This year’s event will take place live online 13–...