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    RAC receives accreditation from National Commission for Certifying Agencies

    RAPS today announced that its Regulatory Affairs Certification (RAC) programs have been accredited through the National Commission for Certifying Agencies (NCCA) , an accrediting body of the Institute for Credentialing Excellence (ICE). NCCA accreditation applies to both the RAC-Drugs and RAC-Devices credentials. NCCA accreditation provides independent, impartial validation that the RAC programs meet stringent industry standards for certification programs. Accreditati...
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    Orphan drug experts discuss new book on developing rare disease treatments

    Developing therapies for rare diseases involves complex incentives, unique requirements, and often extensive patient engagement. The authors of RAPS’ Orphan Drug Development for Rare Diseases , Sundar Ramanan, PhD, MBA, and Sunny Kamlesh Dave, MPharm, recently took time to discuss with RAPS Senior Editor Gloria Hall the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book. During a “m...
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    Need the fundamentals of pharma or device regulations? RAPS’ product-sector books have it covered

    RAPS’ Fundamentals of Regulatory Affairs series of books has been a trusted reference for regulatory professionals for more than two decades since the publication of the first edition of Fundamentals of US Regulatory Affairs . Over the years, more titles have been added to the series, covering not only US regulations, but also those in the EU as well as important international standards. Originally, each fundamentals book covered the full regulatory landscape in a coun...
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    108 more professionals earn RAC

    RAPS today announced that 108 professionals passed the Regulatory Affairs Certification (RAC) exams in the summer exam window, which occurred in July and August 2021. Passing the exam confers the RAC-Drugs and RAC-Devices credentials, the leading credentials for regulatory professionals in the healthcare product sector. There are currently more than 5,000 professionals around the world who hold the RAC credentials.   The RAC exams are rigorous and in order to pass, o...
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    RAPS releases updated Regulatory Competency Framework

    RAPS today announced the release of its updated Regulatory Competency Framework , describing the essential elements of what is required of regulatory professionals at four key career and professional levels. The framework is relevant to regulatory professionals in multiple healthcare product sectors, including pharmaceuticals, medical devices and biotech, and is useful to individual professionals, hiring managers and organizations. “The Regulatory Competency Framework ...
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    RAPS updates website with new look, more intuitive navigation

    RAPS has redesigned its website, updating it with new navigation and features to help make it easier to find exactly what you are looking for. New homepage The first thing you will likely see when visiting RAPS.org is the refreshed, new-look homepage. We have added five prominent navigation blocks right on the homepage, linking you to RAPS’ most sought after content—news, membership information, education offerings, certification information and resources. We also ha...
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    New book covers essential lessons of Rx-to-OTC switch

    More than ever, consumers are looking to over-the-counter (OTC) medicines for treatment options that are easily accessible and often less costly than prescription alternatives. The OTC market in the US is growing. Sales are expected to grow from the $25 billion spent in 2013 to an estimated $42 billion in 2024, a 68% increase. When a prescription medicine is reclassified to be made available without a prescription, it is known as an Rx-to-OTC switch. In such cases, the ...
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    RAPS Convergence 2021 brings regulatory community together virtually to hear from regulators, learn from each other and celebrate the profession

    RAPS today wrapped up its annual RAPS Convergence , the world’s largest conference dedicated to healthcare product regulation and regulatory issues. The event drew more than 1,500 participants again this year—from 37 countries around the globe—in the second year it was held virtually. Convergence 2021 attendees heard from more than 300 expert speakers, including more than 50 from national and regional health authorities and notified bodies from around the world. More t...
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    Global regulatory workforce nearly 100K, says new report from RAPS, Elemed

    Nearly 100,000 professionals around the world currently work in the field of regulatory affairs for healthcare products, such as pharmaceuticals, medical devices, and biotechnology products, including vaccines. This is according to a new joint report from RAPS and Elemed , a leading technical recruiter specializing in regulatory affairs. The Global Regulatory Affairs Professionals Workforce report, previewed this week at the RAPS Convergence 2021 virtual conference...
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    RAPS honors 7 distinguished individuals and an advocacy group for contributions to the regulatory profession and patient health

    RAPS has recognized seven distinguished professionals and one patient advocacy organization with awards for their work to support the regulatory profession and advance public health. RAPS’ Founder’s Award, Community Leadership Award and Patient-Centered Health Award are presented annually during RAPS Convergence , the world’s largest conference dedicated to healthcare product regulation and regulatory issues. This year’s Convergence will take place virtually 12–15 Septemb...
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    Chisholm, Falcone, Soo and Steffen named RAPS Fellows

    RAPS today announced the names of four exceptional senior regulatory professionals who will join the venerated ranks of RAPS Fellows . The 2021 RAPS Fellows are:   Orin Chisholm , FRAPS, BSc (Hons), GCULT, PhD, SFHEA, principal consultant, Pharmed, Sydney, Australia Robert Falcone , FRAPS, PhD, senior manager, regulatory affairs, Prestige Consumer Healthcare Inc., Tarrytown, NY Chin-Wei Soo , FRAPS, DRSc, global regulatory head, devices and combination products,...
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    Top FDA and EMA officials to kick off Convergence 2021

    RAPS will hold its annual Convergence, the world’s largest conference dedicated to healthcare product regulation and regulatory issues, 12–15 September . Convergence 2021 will be a live, virtual event featuring more than 100 educational sessions, presentations, panel discussions, speaker and author meet and greets, and other interactive sessions with more than 200 expert speakers.   The four-day conference will kick off with an opening plenary and panel discussion o...