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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...
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    Experts to provide insight on FDA under Biden during RAPS virtual event

    As the COVID-19 pandemic continues, and the virus’s highly transmissible delta variant fuels a spike in new cases, hospitalizations and deaths, the work of the US Food and Drug Administration (FDA) has arguably never been more critical. The agency made big news again this week as it took the highly anticipated step of granting full approval to the Pfizer-BioNTech coronavirus vaccine. Beyond the front-page headlines, what are the other important developments at FDA reg...
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    RAPS’ new International Fundamentals book includes pandemic-related updates, and a lot more

    There is no question the COVID-19 pandemic has stressed healthcare systems around the world, forced manufacturers and regulators alike to rapidly shift both priorities and processes, and created a broad range of new challenges. It remains to be seen what long-term changes will result from the crisis, but regulatory professionals are already dealing with some of the effects. RAPS’ recently released Fundamentals of International Regulatory Affairs, Fifth Edition , was ...
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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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    Author offers advice for navigating combination products approval pathways

    With few comprehensive resources available covering combination products, RAPS’ recently released book, International Combination Products , by Jocelyn Jennings, MS, RAC (US, Drugs, Devices), fills a significant need for practical guidance on navigating the regulatory pathways for products combining multiple technologies. Prior to writing the book, “there was no place that I found that I could look to find all of the information I was interested in on different topics t...