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    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
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    RAPS congratulates 108 spring RAC exam passers

    RAPS today announced that 108 professionals passed the Regulatory Affairs Certification (RAC) exams in the spring examination window, which occurred in March and April 2022. In doing so, these professionals have obtained their RAC-Drugs or RAC-Devices designation, the leading credentials for regulatory professionals in the healthcare product sector. These 108 individuals join more than 5,000 global professionals who hold RAC certifications. “On behalf of RAPS, I offe...
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    500+ gather in Amsterdam for Euro Convergence, RAPS’ largest-ever European event

    RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years. Euro Convergence is the premier annual event for European regulatory professionals. This year’s event drew more than 500 participants from six continents and 33 countries. Attendees gathered for three days of education sessions, expert presentations and panel discussions curated exclusively by European regulato...
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    RAPS Euro Convergence features speakers from EMA, FDA, and Swiss, Austrian and UK health authorities, as well as notified bodies

    Prominent officials from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), Swiss, Austrian and UK national health authorities, and several notified bodies will speak at the upcoming RAPS Euro Convergence . The annual three-day conference devoted to European healthcare product regulations and regulatory issues will take place, 10–12 May in Amsterdam. More than 120 expert speakers will provide updates and insights on important European regul...
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    FDA continues co-sponsorship of MedCon conference with AFDO/RAPS Healthcare Products Collaborative

    The US Food and Drug Administration (FDA) will continue its longstanding co-sponsorship of the MedCon conference . With a focus on fostering open discussions of the most pressing issues facing the medical device industry, the AFDO/RAPS Healthcare Products Collaborative recently announced that their new partnership will carry on Xavier Heath’s 12-year legacy of delivering the MedCon conference. The MedCon 2022 Conference will be held virtually 4 – 6 May 2022. The even...
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    132 professionals pass Regulatory Affairs Certification (RAC) exams, earning RAC-Devices or RAC-Drugs credentials

    RAPS today announced the names of the 132 professionals who passed one of the two Regulatory Affairs Certification (RAC) exams in autumn 2021. By passing, they earn either the RAC-Drugs or RAC-Devices credential. The RAC credentials are the leading certifications for regulatory professionals in the healthcare product sector and the only regulatory credentials in this sector to be accredited through the National Commission for Certifying Agencies (NCCA). Earning an RAC...
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    RAPS and AFDO partner to further healthcare products industry dialogue, including MedCon conference

    RAPS and the Association of Food and Drug Officials (AFDO) have come together to support sharing, collaboration and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s 12-year legacy of delivering the Xavier MedCon Conference . “The annual MedCon Conference has historically provided outreach and ...
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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 ...