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    Handling Regulatory Challenges: Responding With Grace Under Pressure

    Everyone who chooses a regulatory career learns that it comes with some challenges, and the solutions are not always clear or easy. For a session at the RAPS 2015 Regulatory Convergence in Baltimore last October, Daniela Drago, PhD, who heads up the regulatory affairs program at the George Washington University School of Medicine and Health Sciences, decided to examine some of these challenges with a panel of seasoned regulatory professionals using an interactive a...
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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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    How to be a Regulatory Leader

    Increasingly, regulatory professionals need to be effective leaders. Not only are they leading regulatory departments and cross-functional work groups, they also are being called upon to play key roles on corporate and organizational leadership teams. RAPS’ Scope of Practice Study shows that regulatory professionals now spend up to a third of their time working on strategy or business-related duties. Recognizing the value regulatory experts bring to the C-suite, s...
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    FDA Expresses Desire to Work With Industry on CGMPs for Combo Products

    During RAPS’ and the Combination Products Coalition’s (CPC) recent workshop on current Good Manufacturing Practice (CGMP) for combination products, which took place on 1 April, the US Food and Drug Administration’s (FDA) lead presenter, John Barlow “Barr” Weiner, paused briefly to acknowledge the date’s popular connotation. “I just realized I should’ve inserted some sort of April fools [joke] in this presentation,” said Weiner, who is the associate director for polic...
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    Can Some Medical Devices Skip China's Clinical Trial Mandate?

    In October 2014, the China Food and Drug Administration (CFDA) implemented its new medical device regulations, including new clinical trial requirements and associated submission processes. To market higher-risk products—those designated as class II or III under the Chinese classification system—the device must undergo a registration process that also may require clinical trials be conducted. Foreign device manufacturers need to understand that if clinical tr...