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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 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...
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    122 earn RAC in spring 2021 exam period

    RAPS today announced the names of the 122 professionals who earned Regulatory Affairs Certification (RAC) in the most recent RAC exam period this past spring. The RAC is the leading credential for regulatory professionals in the healthcare product sector. “Congratulations to all who passed the RAC exams! It is a great accomplishment,” said RAPS Interim Executive Director Bill McMoil. “Earning the RAC demonstrates not only regulatory knowledge and critical thinking ski...
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    FDA’s Marks and Shuren to speak at RAPS Convergence opening

    RAPS today announced that two of the US Food and Drug Administration’s (FDA) top officials will appear on a panel during the opening plenary kicking off RAPS Convergence 2021 . Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research (CBER), and Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH), will join a discussion on COVID-19, regulatory affairs, and the impact on patients, on 12 September—the first...
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    PIC/S looks to adopt EU Annex on qualified persons, batch release

    The Pharmaceutical Inspection Cooperation Scheme (PIC/S) this week announced plans to incorporate the EU good manufacturing practice (GMP) Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim is to have non-EU/European Economic Area (EEA) members incorporate Annex 16 into their regulatory systems.   The EU’s Annex 16 covers the certification of a QP that can release product batches for marketing authorization holders in the EU or labeled...
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    RAPS Euro Convergence draws participants from 32 countries to hear from European regulatory experts

    RAPS Euro Convergence 2021 , the premier annual event for European regulatory professionals, wrapped up today after three days of online education sessions, expert presentations and panel discussions, and web-based professional networking opportunities.   Held virtually for the second year, the event drew 370 registrants from six continents and 32 countries. Over the course of 65 sessions, attendees heard from—and had the chance to connect with—168 expert speakers fro...
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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 ...