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  • RAPS' LatestRAPS' Latest

    2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote

    One of the big draws of attending RAPS’ annual Regulatory Convergence is the opportunity to hear directly from regulators. Each year, the Convergence features dozens of speakers and panelists representing global regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the China Food and Drug Administration and many others. Among the highlights of last year’s Convergence in Baltimore was the opportu...
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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...
  • Regulatory NewsRegulatory News

    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
  • 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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    Regulatory Convergence Exhibit Hall Preview

    RAPS’ 2015 Regulatory Convergence is almost here. The signature annual event takes place next week in Baltimore. The opening plenary officially kicks off the conference Monday, 26 October, and everything wraps up Wednesday, the 28th. In between, there will be more than 75 different sessions with more than 300 speakers covering the latest developments in the regulation of pharmaceuticals, biotech, medical devices, health-related foods, regulatory strategy and more....
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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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    Convergence Attendees Can Use New RAPS Mobile App for Info, Fun and Prizes

    Starting today, you will be able to download the new RAPS Events mobile app for Apple and Android devices. The app has been customized for the 2015 Regulatory Convergence conference, taking place 24–28 October in Baltimore, where attendees will get the first chance to try it out. Convergence attendees will be able to use the app on mobile devices to find information about Convergence sessions, speakers, events and activities; share their own photos and comments...
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    Acting FDA Commissioner Stephen Ostroff, Author Daniel Pink to Headline RAPS' Regulatory Convergence Conference in Baltimore

    RAPS’ annual Regulatory Convergence is now less than three weeks away. The event, taking place this year 24–28 October in Baltimore, is the largest annual gathering of the global healthcare regulatory community, including healthcare product regulators, scientists, innovators, and regulatory professionals from life sciences companies of all sizes. This year’s conference will feature keynote remarks from Acting Commissioner of the US Food and Drug Administration (FD...
  • Regulatory NewsRegulatory News

    FDA Raises Fee Rate for Rare Pediatric Disease Priority Reviews for FY2016

    The US Food and Drug Administration (FDA) on Friday announced that it would increase the rare pediatric disease priority review voucher fee rate for FY 2016 by about $200,000. The new rate -- $2,727,000 – is effective on 1 October and will remain in effect for the next year. FDA previously set the fee rates at $2,562,000 for FY 2015 and $2,325,000 for FY 2014. The new rate is based on FDA's estimate that the cost of a standard review for new molecular entity (NME) new dr...
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    Locals Look Forward to Showcasing Baltimore to Convergence Attendees

    With RAPS’ Regulatory Convergence coming to Baltimore, 24–28 October, the signature annual event for the regulatory profession will not only be held within close proximity to the US Food and Drug Administration’s (FDA) Maryland headquarters, it also will return to the home turf of one of RAPS’ most active and enthusiastic chapters. Several local members of the RAPS DC/Baltimore Chapter gathered at Baltimore’s inner harbor recently to record a short welcome ...
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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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    Looking Forward to Seeing You in Baltimore

    As the calendar has turned from August to September, all of us at RAPS headquarters are counting down to RAPS’ Regulatory Convergence , which is now just a few short weeks away. I look forward to welcoming you to the Convergence, 24–28 October in Baltimore. The Convergence is all About Regulatory The Convergence is 100% for and about the regulatory profession. It is about much more than just skimming the surface on regulatory issues. The dynamic educational sess...