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    1,700 Gather in Phoenix for RAPS Convergence 2022

    The Regulatory Affairs Professionals Society (RAPS) concluded its annual RAPS Convergence in Phoenix on Tuesday, 13 September, attracting 1,700 participants from 41 countries across five continents. Attendees gathered in-person for the first time since 2019 for four days of educational sessions, expert presentations and panel discussions exploring the most pressing topics in medical device, IVD and pharmaceutical regulation for global markets.   “In addition to the p...
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    Nearly one in five regulatory professionals changed jobs in 2021, new report shows

    Pay raises, job changes, and new work environments are among the top findings from the RAPS 2022 Global Compensation and Scope of Practice Report for the Regulatory Profession , the largest and most comprehensive research initiative on the global regulatory profession. The report gives regulatory professionals and their employers a one-of-a-kind look at the profession with data on compensation, job responsibilities, career experience, education and more. The report ...
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    How to learn about healthcare product labeling and why it matters for regulatory professionals

    “It all comes down to labeling. It is all about labeling.”  So says Cathleen O’Connell, architect of RAPS new Online University course Pharmaceutical Labeling: Introduction to an Essential Function . She’s also the author of Essentials of Healthcare Product Labeling , a RAPS publication that dives into the subject. Cathleen has more than 20 years of experience in healthcare product labeling as both a practitioner and an educator.  O’Connell joined RAPS for an interv...
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    EMA's Anthony Humphreys to speak at RAPS Convergence 2022

    A top European regulatory official will address regulatory professionals on 11 September in Phoenix at the Regulatory Affairs Professional Society’s (RAPS) annual conference, Convergence . Anthony Humphreys of the European Medicines Agency (EMA) will deliver remarks remotely during the Convergence opening plenary session. As the head of Regulatory Science and Innovation, Humphreys is responsible for ensuring that the EMA provides a continuous future-proofing through ope...
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    Why these 5 regulatory professionals can’t wait for RAPS Convergence 2022

    RAPS Convergence is a cornerstone of education and networking for regulatory affairs professionals. After two years of virtual conferences, the premier regulatory affairs gathering is once again a live event.  Regulatory professionals are taking over Phoenix, AZ. from Sept. 11-13 for RAPS Convergence 2022 . We’ll descend on the Phoenix Convention Center for three days of connection, education and inspiration. It’s time to reunite. The Convergence 2022 Planning Committe...
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    RAPS honors 11 distinguished professionals and one advocacy group with 2022 awards

    The Regulatory Affairs Professionals Society (RAPS) recognizes 11 distinguished professionals and one patient-advocacy organization with awards for their support of the regulatory profession and work toward advancing 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. RAPS Conve...
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    RAPS announces the 2022 Fellows Program recipients

    The Regulatory Affairs Professionals Society (RAPS) has named 10 exceptional senior regulatory professionals to the distinguished ranks of the RAPS Fellows Program. The 2022 RAPS Fellows are:   Kimberly Belsky, FRAPS, MS, Executive Director, Regulatory Policy & Intelligence and AdPromo, Mallinckrodt Pharmaceuticals  Paul C. Brooks, FRAPS, Retired  Monique J. Carter, FRAPS, MS, RAC-US, Senior Director and Global Regulatory Lead, Pfizer  Niedre M. Heckman, F...
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    FDA commissioner Robert Califf to speak at RAPS Convergence 2022

    The Regulatory Affairs Professionals Society (RAPS) is pleased to announce that US Food and Drug Administration (FDA) Commissioner Robert Califf, MD will speak at RAPS Convergence 2022, 11-13 September, in Phoenix, AZ at the Phoenix Convention Center.   After holding two years of virtual conferences, Convergence will commence its return to an in-person meeting with an opening plenary session where Califf will present on 11 September at 4:30 pm MDT. The commissioner w...
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    RAPS announces board slate for term beginning in 2023

    The RAPS nominating committee has selected the slate of new members set to join the RAPS Board of Directors for its next term, beginning 1 January 2023. The committee carefully reviewed submitted nominations materials and made its selections based on professional experience, substantive involvement with RAPS and a clearly articulated vision for expanding the global reach of the organization and advancing the regulatory profession. The following members are set to j...
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    What it’s like to present a poster at Euro Convergence, with Raquel Carnero

    Euro Convergence, RAPS’ annual gathering of medical device, in vitro diagnostic (IVD) and pharmaceutical regulatory professionals, returned in person to Amsterdam on 11-13 May 2022 . More than 500 participants, including 120 industry expert speakers from more than 30 health authorities and notified bodies, made it an event to remember in Amsterdam after two years of virtual conferences. Delegates submitted a record-breaking 20 posters for Euro Convergence 2022. Raque...
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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...