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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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    New Fundamentals of US Regulatory Affairs Book Now Available

    RAPS has just published the updated, ninth edition of Fundamentals of US Regulatory Affairs , the book that has become one of the most essential references for regulatory professionals working with healthcare products for the US market. The new edition is now available  in a print, hardcover edition or as an e-book. RAPS currently is offering free shipping for the book and for all orders from the RAPS Store through 31 August. Fundamentals of US Regulatory Affa...
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    184 Earn Regulatory Affairs Certification in Spring 2015

    RAPS congratulates the 184 professionals who earned their  Regulatory Affairs Certification (RAC)   in spring 2015, the most recent group to do so. The RAC is the only professional credential for the healthcare product regulatory field. It is earned by passing one of the four RAC exams and must be maintained through continuous learning, professional development and leadership activities. The deadline to  apply  for the next exam cycle taking place this...
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    US RAC Prep Webcast Series to Kick Off 15 July

    While the Regulatory Affairs Certification (RAC) exams are experience-based and intended for professionals who have been working in the field for three to five years, don’t misinterpret that to mean you can rely solely on your professional experience and expect to pass with ease. The success rate for the exams is typically between 40% and 50%. When it comes to passing any of the four RAC exams , effective preparation is critical. On 15 July, RAP...
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    RAPS, National University of Singapore Gear up for 2nd Year of Certificate Program

    Last year, RAPS and the National University of Singapore (NUS) launched a joint graduate certificate program in Medical Devices Regulatory Affairs (MDRA) for Singapore-based regulatory professionals. The program was developed in partnership with Singapore’s government as part of its effort to help cultivate the highly competent regulatory workforce needed to support the country’s growing medical technology industry. The first year of the MDRA certificate program ...
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    Should You Pursue a Master's Degree or a Regulatory Affairs Certificate?

    There is mounting evidence that pursuing a professional or graduate certificate may be a very savvy career investment. The popularity of certificates is on the rise. According to a 2012 study from the Georgetown University Center on Education and the Workforce, certificates are the fastest growing postsecondary credential, and second only to bachelor’s degrees in the number earned each year. About 10% of regulatory professionals now have postgraduate certifica...
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    FDA Seeks New Top Press Official for its Office of Media Affairs

    The US Food and Drug Administration (FDA) has started its search for a new leader for its Office of Media Affairs , better known simply as FDA's Press Office. In a job notice posted on 2 March 2015, the agency said it's looking for a new assistant commissioner for media affairs—a position which has long been in a state of flux. The office is currently overseen by Acting Assistant Commissioner Heidi Rebello, who took over from former Acting Assistant Commissioner Eric...
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    How to Schedule Your RAC Exam

    One simple but important step in your quest for Regulatory Affairs Certification (RAC) is scheduling your exam. The four RAC exams are computer-based and are offered at testing centers around the world during the April–May and October–November exam periods, so regardless of which exam you wish to take, there will be a number of possible locations and dates available. Once you have registered for the exam of your choice, about 15 days before the exam c...
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    RAC Eligibility Explained

    If you are considering taking one of the four Regulatory Affairs Certification (RAC) exams, one of the first things you need to do is determine whether you meet the exam eligibility requirements . The criteria are not complicated, but since they were changed—the updated criteria went into effect beginning with the autumn 2014 exam period—there may be some lingering confusion over the exact requirements. To be eligible to take the RAC exam, you must have at least a bac...
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    The Four RAC Credentials Explained

    Perhaps you have decided to pursue Regulatory Affairs Certification (RAC), or you are interested in it, but are unsure which of the four RAC credentials is the best fit for you. A previous article examined factors to consider in determining if the RAC is right for you . If you need to assess whether or not to pursue an RAC, you may want to start there. In this article, I will address the question of which RAC credential is right for you. The RAC Credentia...
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    Immergut, FDA's Top Communications Official, Stepping Down

    The US Food and Drug Administration's (FDA) top communications official, Steven Immergut, is set to leave the agency next month to "pursue other opportunities," according to FDA officials. Immergut, who currently serves as acting associate commissioner for external affairs (EA), has been with the agency for three years, having joined the agency in 2011 as the assistant commissioner for media affairs. Immergut has been in his current position since December 2013, when he ...
  • Regulatory NewsRegulatory News

    FDA Announces Major Regulatory Changes, With Specialization a Key Focus

    Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products. Background In September 2013, FDA announced to internal staff that, in response to "unparalleled challenges" posed by advances in product complexity and globalization, FDA would be forming a new "Program Alignm...