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    Embracing Change in EU Medical Device Regulation: The Notified Body Perspective

    The RAPS San Francisco Bay Area Chapter kicked off 2014 with a 7 March conference focused on the proposed EU medical device regulations. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. The message was clear-change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. A BSI Healthcare medical device expert team p...
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    RAPS DC/Baltimore Chapter Career Day Offers Insight, Opportunity to Meet Employers

    • 10 June 2013
    "Don't always assume you don't have the experience." That was the message to, students, graduates and seasoned regulatory professionals from Andrea Chamblee, regulatory counsel, US Food and Drug Administration (FDA). She presented her insights at the Regulatory Affairs Professionals Society (RAPS) DC/Baltimore Chapter Career Day, 11 May 2013. Nearly 100 people participated in the event held at the Johns Hopkins University Montgomery County Campus. Attendees were welcomed...
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    Finding the Perfect Match: Mentors Guide Professionals

    Did you ever want career advice, but had no one to ask? Needed insight about informational interviews, but did not want to rely on the Internet? The RAPS Washington, DC/Baltimore Chapter hosted a "Mentor-Mentee: Match Making" event to bring together those seeking information with those who have it. Fourteen RAPS members participated at the RAPS training center in Rockville, MD on 21 June 2012. These individuals, representing the academic, not-for-profit, federal and c...
  • Deadline for Mandatory Submission of Drug Sample Information to FDA Closes Soon

    The US Food and Drug Administration (FDA) released updates this week (26 March) on submitting information required under the Patient Protection and Affordable Care Act (PPACA) . Under the law, pharmaceutical companies are required to submit certain drug sample information to FDA before 1 April 2012 and every year thereafter. Under the PPACA's Section 6004, " Prescription Drug Sample Transparency ," manufacturers must submit: the identity and quantity of drug samples...