• RAPS' LatestRAPS' Latest

    RAPS DC-Baltimore Chapter Meets for Fun and Networking

    Despite warnings of a massive snow storm, members and guests of the RAPS DC/Baltimore Chapter gathered for an evening meet-up 21 January at Union Jacks pub in Bethesda, MD. As they arrived, people joined in a game to "find the D-RAP," with "D-RAP" meaning the designated regulatory affairs professional. Attendees simply had to talk to one another in order to play. Then they formed groups to discuss topics such as how regulatory professionals can distinguish t...
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    The Art of Saying Yes and No

    ‘Yes’ and ‘no’ are two simple words in the English language, but they generate a vast array of mind-boggling complexities when used incorrectly—whether intentionally or unintentionally. How many of us have said yes when we actually wanted to say—or should have said—no, and vice versa? Imagine you are invited to party you have no desire to attend, and inside you are screaming “no,” but you say yes because you do not want to offend the host or wish others to think y...
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    RAPS Southeast Regional Career Day Educates Participants on Regulatory Careers

    After participating in the RAPS DC/Baltimore Chapter’s career day in 2014, Marcia Johnson, RAC, CBA, was inspired to create a similar event closer to home in the Atlanta area. Together with the Chair of the RAPS Atlanta Chapter, Penny Northcutt, RAC, FRAPS; Grace Powers, RAC; and several chapter volunteers, Marcia started pulling together sponsors and panelists. On 8 October 2015, the RAPS Southeast Regional Career Day brought together those interested in regulatory ...
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    Sherry Keramidas: An Interview With RAPS’ Outgoing Executive Director

    Regulatory Focus sat down Thursday with Sherry Keramidas, PhD, FASAE, CAE, who for the past 20 years has run the Regulatory Affairs Professionals Society (RAPS) as executive director but will be signing off at the end of January. Keramidas’ extensive work in the regulatory affairs profession has broadened not only the scope of the field and the work undertaken by regulatory professionals, but she also helped to develop a certification program for the increasingly glo...
  • Regulatory NewsRegulatory News

    In Focus: The Top News Stories from 2015

    For RAPS’ Regulatory Focus , 2015 might simply be called: The Year of the Explainer. With major legislation altering the inner workings of the US Food and Drug Administration (FDA), as well as new priority review voucher programs coming to fruition, RAPS’ reader interest has been spiking for longer, more in-depth articles. Without further ado, here are the top most-read articles in 2015 based on traffic statistics: 9. After Three-Year Delay, FDA Finalizes Guidance Do...
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    RAPS Announces Holiday Schedule

    RAPS will close its headquarters office this year from Christmas Day until 4 January 2016. However, during the office closure, online orders may still be placed and will be shipped. Please note: some orders placed 22 and 31 December may experience slight delays. RAPS’ free shipping offer on any orders placed in December is still in effect. Regulatory Focus will publish news items and distribute issues of the RF Today e-newsletter until 23 December, then be on hiatu...
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    RAPS Announces Retirement of Executive Director

    • 11 December 2015
    RAPS announced today the retirement of its Executive Director Sherry Keramidas whose leadership during a 20-year tenure helped advance the healthcare regulatory profession. She will retire on 31 January 2016. “Sherry has served RAPS and its members during a critical period of change in the healthcare industry,” according to RAPS Chairman of the Board Rainer Voelksen. “Her constancy throughout ensured RAPS’ mission to provide leading education and professional deve...
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    10 Outstanding Regulatory Professionals to be Honored as RAPS Fellows

    RAPS today announced its 2015 class of RAPS Fellows. The Fellows will be honored Monday, 26 October, during the opening plenary of RAPS’ Regulatory Convergence conference in Baltimore. The Convergence is the largest annual gathering of the global healthcare regulatory community. The RAPS Fellows program recognizes senior regulatory professionals for their continued contributions and leadership toward the advancement of the profession and the professional. ...
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    Q & A With Regulatory Convergence Keynoter, Behavior Expert Daniel Pink

    Best-selling author, TV host, behavior expert and Regulatory Convergence keynote speaker Daniel Pink has spent years looking at why people do the things they do, and how sometimes subtle changes can make big differences in their behaviors. As host of The National Geographic Channel’s Crowd Control , he has conducted fascinating experiments that show just how some of these changes play out in real-world situations, and how social science can be used to tackle r...
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    RAPS to Host Career Fair in Minneapolis

    On 24 September, RAPS will host a career fair for regulatory professionals and other interested job seekers in Minneapolis. The fair will take place 5:30–8:30 pm at the Marriott Minneapolis West and will give attendees a chance to network and meet in person with hiring managers and recruiters from a number of leading medical device and biotech organizations seeking to fill regulatory positions in the Twin Cities area. Participating exhibitors include: ACI...
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    RAPS to Host San Jose Career Fair

    On 10 September, RAPS will host a career fair and networking event for regulatory job seekers and employers in the San Jose area. The event will be held from 5:30 to 8:30 pm PDT at the Biltmore Hotel & Suites in Santa Clara, CA, and will give attendees a chance to network and meet in person to discuss open regulatory positions and career opportunities. The career fair is free for job seekers to attend. To register, fill out this online form . Employers int...
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    Chicago Workshop to Help Regulatory Pros Communicate More Effectively

    Most regulatory professionals do not have a background—or often any training at all—in communications. Yet they are called upon every day to be effective communicators. Whether it’s communicating with their peers on a regulatory team, colleagues in other areas within their organizations, upper management, regulators, researchers, contractors or others, regulatory pros need to be clear, establish credibility and influence people in different disciplines and at many d...