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    John Lim, Justina Molzon, Barbara Schneeman and Mike Ward to Receive RAPS’ Highest Honor

    RAPS has announced the recipients of its 2018 Founder’s Award. They are: John Lim, MD, executive director, Center of Regulatory Excellence, Singapore; Justina Molzon, JD, former associate center director for international programs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA); Barbara Schneeman, PhD, former director, Office of Nutrition, Labeling and Dietary Supplements, FDA; and Mike Ward, coordinator, Regulatory System Strengthen...
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    RAPS to Honor Lena Cordie, Alan McEmber for Outstanding Community Leadership

    RAPS has announced the recipients of its 2018 Community Leadership Award. They are: Lena Cordie, president, Qualitas Professional Services, and Alan McEmber, MS, RAC, head, therapeutic area regulatory strategy, Shire. The Community Leadership Award recognizes RAPS members who have helped build thriving local networks, supported fellow regulatory professionals and acted as RAPS ambassadors. Cordie and McEmber will be honored and receive their awards next week during RAP...
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    Daniel Mannix, Sandra Matsumoto and Frank Pokrop Named RAPS Fellows

    RAPS today announced the names of its 2018 class of RAPS Fellows. Daniel Mannix, PhD, FRAPS, vice president, regulatory affairs, MacroGenics Inc.; Sandra Matsumoto, PhD, RAC, FRAPS, vice president, regulatory affairs, Sebela Pharmaceuticals; and Frank Pokrop, CPGP, CQA, CQE, CSQE, RAC, FRAPS, senior director, regulatory affairs and quality assurance, Sotera Wireless, are the latest to join this elite group of accomplished regulatory professionals, the RAPS Fellows . Th...
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    8 Networking Tips for Regulatory Convergence Attendees

    The 2018 RAPS Regulatory Convergence at the Vancouver Convention Centre in Vancouver, BC, 1–4 October, will offer attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. At the Convergence, you will be surrounded by people who truly ‘get it.’ They understand regulatory issues, and have gathered together to examine them in depth, share ideas and meet other like-minded pr...
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    10 Ways to Get the Most From RAPS' Regulatory Convergence

    Your time is valuable. We respect and appreciate the time you take to attend the  Regulatory Convergence , and we want you to get as much out of RAPS’ signature annual event as you can. After all, it is an investment in your job, your career and your regulatory knowledge. And for those of you who may be first-time attendees, it can be particularly helpful to have an idea of what to expect. So we have a few tips to help you make the most of your Convergence experience this...
  • Regulatory NewsRegulatory News

    FDA Warns Swedish IVD Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II  in vitro  diagnostic (IVD) devices. The warning, following an inspection last January, features at least five violations, including one related to the company’s decision to not recall an assay used to detect anti-nuclear antibodies after receiving complaints of a higher incidence of false p...
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    Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

    • 28 September 2017
    US Food and Drug Administration Commissioner Scott Gottlieb addressed attendees of RAPS’ 2017 Regulatory Convergence on 11 September. He focused his remarks on making the clinical end of drug development more efficient and effective . If you missed it or would like to see his presentation again, the video is embedded below.
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    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...
  • Regulatory NewsRegulatory News

    10 Hot-Button Issues FDA’s New Commissioner Will Face

    Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...
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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...