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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...
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    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 ...
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    RAPS Celebrates National Puzzle Day With Regulatory Crossword

    Today is National Puzzle Day in the US. To mark the occasion and have a little fun, RAPS has created a crossword puzzle just for regulatory professionals. Download RAPS’ Regulatory Word Challenge here , and when you’re ready, download the answers here , or use the links below. The puzzle’s answers include words from the areas of pharma, biotech and medical devices, so those with a varied background may have bit of an edge. The Regulatory Word Challenge is...
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    UPDATE: Showcase Your Expertise at Regulatory Convergence Proposal Deadline Extended

    RAPS is continuing to accept presentation proposals for the 2017 Regulatory Convergence to be held 9–12 September at National Harbor, MD, and the deadline has been extended. All proposals are now due Friday, 27 January. The Convergence is RAPS’ signature annual conference and the largest annual gathering of regulatory professionals in the world. Participating as a speaker or session leader offers an opportunity for regulatory experts to share their knowledge and...
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    RAPS' New Board of Directors Begins 2017 Term

    The 2017 term for the RAPS board of directors of began officially on 1 January. For the new term, Todd Chermak of Abbott Established Pharmaceuticals takes over as chairman. “I am extremely proud to serve as chairman of the RAPS board of directors,” said Chermak. “RAPS plays an important role in helping regulatory professionals effectively perform their critically important jobs and in promoting regulatory excellence at all levels. I look forward to playing a key r...
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    RAPS Holiday Schedule Announced

    RAPS headquarters will close this year the week of 26 December and reopen 3 January 2017. Online orders from the RAPS Store may still be placed and will be shipped while the office is closed, and RAPS will still take 20% off all orders placed in December with the code: DEC20OFF. However, please note shipping times may be delayed for orders placed from 23 December through 4 January. Regulatory Focus will publish news and the RF Today e-newsletter will continue d...