• Regulatory NewsRegulatory News

    Reorganization of OND to Support New Drug Review Modernization, Woodcock Says

    The reorganization of the US Food and Drug Administration’s (FDA) Office of New Drugs will help support the modernization of new drug reviews, Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research told attendees of RAPS’ Regulatory Convergence on Thursday. She said the plan is to begin restructuring the premarket safety review process and then move into the investigational new drug (IND) application process. By frontloading a lot of the activities, th...
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    Survey: Expected Shortage of Notified Bodies Under EU MDR/IVDR

    Findings from a recent survey of notified bodies (NB) in Europe suggests the audits needed for compliance with the new medical device regulation (MDR) will not be completed in time, TÜV SÜD Product Service GmbH VP Bassil Akra said Wednesday at 2018 Regulatory Convergence.   The survey conducted by Team-NB was designed to assess the impact of a contentious issue with regard to the ongoing transition to the new EU MDR and in vitro diagnostic regulation (IVDR). This r...
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    RAPS Releases Results of Compensation Survey of Regulatory Professionals

    RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved. RAPS’ 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession aggregates salary data for more than 2,300 respondents from 64 countries and breaks down median and averag...
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    RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)

    RAPS today announced two new Regulatory Affairs Certifications (RACs) will become available beginning with the next RAC exam period in spring 2019. Exam applications are now being accepted. The two new exams and associated credentials are called the RAC (Drugs) and RAC (Devices). They join the four previously established, regional exams: US, EU, Canada and Global. The RAC is the only post-academic professional credential for the healthcare product regulatory field....
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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...
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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 ...