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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 ...
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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...
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    RAPS' Regulatory Exchange Wins 'Most Successful Community' Award

    RAPS’ members-only online community, Regulatory Exchange or “RegEx” as it is often called, was recently named one of three “Most Successful Community” award winners of 2016 by Higher Logic. RegEx is built on the Higher Logic platform. Award winners were honored during the company’s recent Super Forum event in Arlington, VA. The annual awards highlight and celebrate the company’s clients that have achieved significant results through the implementation and us...
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    Six Expert Regulatory Professionals Honored as RAPS Fellows

    Last week at RAPS’  Regulatory Convergence  in San Jose, CA, RAPS honored six regulatory experts who recently joined the elite ranks of RAPS Fellows. The RAPS Fellows program recognizes senior regulatory professionals for their continued contributions and leadership toward the advancement of the profession and the professional. Being named a RAPS Fellow is a significant accomplishment within the regulatory profession. RAPS Fellows serve as important resources for ...
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    Convergence Exhibit Hall Offers Fun, Prizes, Personal Connections

    The 2016 Regulatory Convergence will kick off this Sunday evening in San Jose, CA. Following the opening keynote presentation from R “Ray” Wang , attendees will be treated to a grand opening reception in the Convergence’s exhibit hall. The Taste of Northern California Reception will give the 2,000 expected participants a chance to sample local fare and famous Napa Valley wine as they socialize and get a first look at the more 100 exhibitors at this year’s event...
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    RAPS' New Book Offers 36 Articles on Eclectic Science Topics for Curious Readers

    RAPS has just published a new book that offers curious readers a collection of 36 brief, interesting articles on a range of science and regulatory topics, some published for the first time. The new book, Eclectic Science and Regulatory Compliance: Stories for the Curious , by Max Sherman, is a follow-up to his popular 2012 book From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories . Topics Sherman covers in Eclectic Science include mindful...