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    RAPS Switzerland Chapter Becomes Official Nonprofit Association Under Swiss Law

    RAPS announced today that its RAPS Switzerland Chapter has completed the official registration process as a not-for-profit association under Swiss law. The announcement was made during RAPS’ 2017 Regulatory Convergence conference taking place at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September. While the group has been an official RAPS chapter since 2011, this new status gives it additional l...
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    RAPS' First Chapter Celebrates 25 Years

    As head of the RAPS Bay Area Chapter , Shaalini Doan is eager to welcome RAPS members to San Jose, CA, for the upcoming annual gathering of the global regulatory profession. “The Bay Area is the perfect place to host the 2016 Regulatory Convergence , especially since this year we have the chance to celebrate two significant milestones—the 25th anniversary of our local chapter along with the 40th anniversary of RAPS!” The Bay Area Chapter is the original l...
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    RAPS DC-Baltimore Chapter to Host Career Day This Weekend

    The RAPS DC/Baltimore Chapter will once again host its Mid-Atlantic Career Day this Saturday, 21 May, on the Johns Hopkins University Montgomery County campus in Rockville, MD. This is the third year for the popular event, which in past years has drawn more than 100 attendees from all around the mid-Atlantic region and beyond. This year’s career day comes as the US Food and Drug Administration (FDA) is placing a strong emphasis on developing a strong FDA wo...
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    RAPS Chicago Chapter to Host 2nd Annual Midwest Career Day

    This Saturday, 7 May, the RAPS Chicago Chapter will host its second annual Midwest Regulatory Career Day . The event will go from 10 am to 3:30 pm at the Hilton Garden Inn in Mettawa, IL. Speakers will include regulatory professionals working in industry, consulting and the US Food and Drug Administration (FDA), as well as career experts and representatives from several respected regulatory and related academic programs. View the full program agenda online. ...
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    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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    Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

    The following chapter is an excerpt taken from  Fundamentals of EU Regulatory Affairs, Seventh Edition . Objectives Introduce the problem of falsified medicines Define falsified and counterfeit medicines Define active substances and excipients Explain the aims and scope of the Falsified Medicines Directive ( FMD ) Directive 2011/62/EU ) Identify requirements for different stakeholders in the medicines supply chain arising from the FMD ...
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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...
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    Book Excerpt: Fundamentals of US Regulatory Affairs, Ninth Edition, Chapter 41: Regulatory Information Resources in Review

    The following chapter is an excerpt taken from Fundamentals of US Regulatory Affairs, Ninth Edition OBJECTIVES Become familiar with information resources relevant to the healthcare regulatory industry Learn where to access and retrieve publicly available government, industry and association resources to build regulatory intelligence Recognize the value of meetings and continued learning programs available for professional knowledge and development ...
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    RAPS Mid-Atlantic Career Day Draws Nearly 100 to Learn, Network

    Earlier this month, nearly 100 regulatory professionals, career changers, students and others gathered at the Montgomery County (MD) campus of Johns Hopkins University to learn, network and perhaps take the next steps in their regulatory careers. This was the second year for this regional career event. It was organized by RAPS DC/Baltimore Chapter Co-Chairs Nancy Singer (pictured), RAC, FRAPS, JD, president, Compliance Alliance LLC; and Daniela Drago, PhD, assis...
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    Regulatory Pros and Hopefuls Gather in Chicago for Midwest Career Day

    The first-ever RAPS Midwest Regional Career Day was held last month outside Chicago, attracting 75 attendees from surrounding areas and as far away as Minneapolis and Louisville, KY. Attendees came to network, meet with recruiters and hear presentations from a range of speakers. Presenters included the event organizers from the RAPS Chicago Chapter, several experienced regulatory professionals talking about their own career paths, job search experts, an investigator...