• RAPS' LatestRAPS' Latest

    National Harbor Dine-Around Restaurants Offer Great Food, Convenient Locations

    For attendees of the RAPS 2017 Regulatory Convergence , the National Harbor offers not only a great venue to meet and learn, but also convenient evening dining options. If you have attended Convergence in the past you probably know that the “dine-arounds,” where you sign up for a group meal with fellow attendees, is one of the conference’s most popular social opportunities. This year’s dine-around restaurants are all located right at the National Harbor, just ste...
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    Diermeier to Give Convergence Opening Remarks Gottlieb Keynote Moved to Monday

    University of Chicago Provost Daniel Diermeier will be the featured speaker at the opening plenary session of the 2017 RAPS Regulatory Convergence conference on 10 September. A keynote presentation from US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, originally scheduled to be part of the opening session will now take place a during lunchtime session on Monday, 11 September. The RAPS Convergence takes place at the Gaylord National Resort ...
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    UPDATE: FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, will address the global regulatory community on 11 September, delivering keynote remarks at the 2017 Regulatory Convergence conference at National Harbor on the DC Waterfront. The commissioner's keynote presentation was originally scheduled to take place during the opening plenary session, but is now scheduled as a lunchtime session on Monday, 11 September. The Convergence will take place 9–12 Septem...
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    Six Highly Accomplished Regulatory Pros to Join the Ranks of RAPS Fellows

    RAPS has revealed the names of the six outstanding senior regulatory professionals who will join the elite group of RAPS Fellows this year. They will be recognized during the opening plenary session of the RAPS Regulatory Convergence conference at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September. “To be selected as a RAPS Fellow is an honor reserved for senior regulatory professionals who ha...
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    RAPS Honors Regulatory Leaders With Two New Awards

    RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference, being held at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September . Four outstanding individuals who have had a profound impact on the regulatory profession during their careers will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees...
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    RAPS Publishes 10th Edition of Fundamentals of US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices, Biopharmaceuticals

    RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs , the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market. The book is an essential reference for anyone responsible for products that must comply with regulations from the US Food and Drug Administration (FDA) and other relevant US agencies. The first edition of US ...
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    192 Earned Regulatory Affairs Certification (RAC) in Spring 2017

    Today, RAPS congratulates the 192 regulatory professionals who earned Regulatory Affairs Certification (RAC) during the recent spring 2017 exam period. The RAC credential is earned by passing one of four exams , and is the only professional credential specifically for regulatory professionals in the healthcare product sector. RAC holders must maintain their certification through continuous learning and professional development, recertifying every three years. Currentl...
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    RAPS Seeks Applications for 2017 Fellows

    RAPS  is seeking applications for the 2017 class of RAPS Fellows. Since 2008, the RAPS Fellows program has recognized senior-level regulatory professionals for continued significant contributions to, and leadership in advancing, the global regulatory profession. “Being named a RAPS Fellow is an honor reserved for those who have truly shown exceptional commitment to the regulatory profession,” said Fellows Selection Committee Chair Nancy Gertlar, RAC, FRAPS. “F...
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    Remembering RAPS Founder Richard Greco

    RAPS Founder Richard E. Greco died last week near his home outside of Buffalo, NY. He was 87 years old. During his career, he served as vice president for regulatory affairs with Life Technologies and president of Regulatory Associates Inc. He has been honored by the US Food and Drug Administration (FDA) with the Commissioner’s Special Citation, and in 1979, he become the inaugural honoree of the eponymous Richard E. Greco Award from RAPS. Greco founded RAPS in 1...
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    RAPS Seeks Board Nominations

    RAPS has begun the nomination process for openings for the 2018–2020 term of its board of directors , and is now accepting nominations for president-elect and up to four director positions. Nominees must be active RAPS members in good standing, and all completed nominations applications and supporting materials are due 31 March . For more information visit: Board of Directors Nomination Process . At least two letters in support of the nomination should be ema...
  • Regulatory NewsRegulatory News

    May Deadline for FDA's eCTD Transition Approaches

    Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) all New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New Drug Applications (ANDAs) using the electronic Common Technical Document (eCTD). Drug Master Files (DMFs), Biological Product Files (BPFs)...
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    Is Regulatory Affairs Certification Right for You?

    If you are a regulatory professional considering pursuing Regulatory Affairs Certification (RAC), you are not alone. RAC is a recurring topic of discussion in online forums where regulatory professionals and those looking to get into the profession ask questions and exchange ideas, such as the Regulatory Open Forum on RAPS' Regulatory Exchange , the RAPS LinkedIn group discussion or ...