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    RAPS Euro Convergence: A preview

    RAPS Euro Convergence is just around the corner. The three-day conference devoted to European healthcare product regulations and regulatory issues kicks off Monday 10 May, running through 12 May. Pre-conference workshops begin Friday, 7 May.   This year’s all-virtual program will feature more than 130 expert speakers and more than 40 educational sessions. Attendees will hear from speakers representing the European Commission (EC), the European Medicines Agency (EMA),...
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    138 Global Professionals Earn Regulatory Affairs Certification (RAC) in Autumn 2020

    RAPS announced today the names of 138 individuals who passed Regulatory Affairs Certification (RAC) exams last autumn. By passing the rigorous exam, they earn the RAC, the leading credential for regulatory professionals in the healthcare product sector. The RAC exams test knowledge of regulations governing pharmaceutical products or medical devices, depending on which version of the exam—RAC Drugs or RAC Devices—is taken, as well as how the regulations are applied in ...
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    RAPS relaunches enhanced Regipedia, the wiki built for regulatory pros

    RAPS has relaunched its member-exclusive, RAPS Regipedia , an online wiki compilation of regulatory terms and definitions originally derived from RAPS’ Acronyms & Definitions guides. The Acronyms & Definitions guides have been on regulatory professionals’ bookshelves for nearly two decades as handy references for looking up all manner of terms related to the regulation of drugs, medical devices, biologics and other healthcare products. RAPS used the content of thos...
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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 members get new health insurance benefit through partnership with LIG Solutions

    • 03 November 2020
    • By
    US-based RAPS members, their families, and their businesses and employees can now access exclusive affordable healthcare insurance coverage through a new member benefit program in partnership with LIG Solutions. Available plans include coverage options for major medical, Medicare, short term policies, vision, dental, critical care, and supplemental insurance coverage as well as health reimbursement arrangements (HRAs). “We want to provide access to quality healthcare pr...
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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’ 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...