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  • RAPS' LatestRAPS' Latest

    RAPS Euro Convergence to address Europe’s top regulatory challenges, say conference co-chairs

    RAPS’ 2020 Euro Convergence kicks off in less than three weeks. The conference, which had originally been scheduled to take place in Brussels in May, will be held all online, 26–30 October. It follows the successful, first-ever virtual RAPS Convergence last month, and comes at a crucial time for the life sciences sector in Europe. Even before the COVID-19 pandemic, regulatory professionals working with products for the European market had their hands full. The pendi...
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    RAPS’ updated book on regulatory strategy for devices serves as ‘how to’ guide

    Constant innovation in medical technology, globalization, pressure on medical device makers to control costs and demonstrate clear benefits to patients, and increased scrutiny from regulators make having a sound regulatory strategy more critical than ever. The recently released second edition of RAPS’ Global Medical Device Regulatory Strategy book provides a “how to" guide to developing a comprehensive regulatory strategy for bringing all types of devices to the global...
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    First virtual RAPS Convergence draws nearly 1,500 participants, earns praise

    RAPS last week wrapped up its first RAPS Convergence conference to be held completely online. RAPS Convergence is the largest annual gathering of the global healthcare regulatory community and the only US event exclusively dedicated to the regulatory profession. RAPS completely redesigned this year’s conference, transforming what has traditionally been a face-to-face event in a different host city each year, into a live, virtual, interactive experience for the nearly ...
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    RAPS offers sneak peek of first virtual Convergence

    With the 2020 RAPS Convergence set to begin a fully-virtual experience for the first time ever next month, and just ahead of the 14 August early bird deadline , RAPS has posted a new video to help attendees and potential attendees get a better feel for the live, online event.   Offering a sneak peek of key elements of the 2020 Convergence to be held September 13–16, the video highlights the record participation by global health authority speakers, inspiring pl...
  • Feature ArticlesFeature Articles

    Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

    This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical...
  • Feature ArticlesFeature Articles

    Managing uncertainty: Regulatory reporting in multinational trials during COVID-19

    This article discusses regulatory reporting challenges for multinational clinical trials during the COVID-19 pandemic. The author covers the pandemic’s impact on clinical research, national guidelines, and harmonization, as well as the challenge of assessing what is reportable and how to submit COVID-19 risk mitigation measures. She offers real-world experience on how she and her colleagues stopped and restarted recruitment in ongoing multinational clinical trials, and how...
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    RAPS Euro Convergence to be held online and in-person in Brussels, 26–30 October

    RAPS announced today that the format for its Euro Convergence 2020 , taking place 26–30 October in Brussels, has been redesigned as a hybrid online and in-person event. Attendees can now experience Euro Convergence by attending in Brussels at the Radisson Blu hotel and/or virtually via a robust, online platform. The conference, which originally had been scheduled for May, was updated and rescheduled in the wake of the COVID-19 pandemic to allow access to this important Eu...
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    Update: RAPS Convergence 2020 goes live online this September

    The RAPS Convergence conference will transition to a virtual-only experience for the first time ever in 2020, with two registration options for its upcoming annual event, which was originally planned to convene in San Antonio, TX. In addition, the event dates have been adjusted slightly to accommodate the new format and will take place 13–16 September. RAPS Convergence is the largest annual gathering of the global healthcare regulatory community and the only U.S. event e...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: EMA shares advice on validated computer systems used in clinical trials

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA shares advice on validated computerized systems used in clinical trials   The European Medicines Agency (EMA) has published a notice about validating and qualifying all types of computerized systems used in clinical trials. EMA released the notice in response to “recent inspection findings” and their implications for the “integrity, reliability, robustness and accep...
  • ReconRecon

    Recon: Abbott beats quarterly profit estimates; UK approves Penlon ventilator for COVID-19

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Chaotic search for coronavirus treatments undermines efforts, experts say ( Washington Post ) House Speaker Pelosi calls Trump WHO decision sen...
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    Recon: Merck launches trastuzumab biosimilar in US; Fujifilm boosts Avigan production

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Coronavirus testing hits dramatic slowdown in US ( Politico ) Trump's halt to WHO funding prompts condemnation as coronavirus cases near 2 mill...
  • ReconRecon

    Recon: GSK, Sanofi team up for coronavirus vaccine; India to boost domestic API production

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Trump: It's my decision when to reopen US economy ( Reuters ) ( NPR ) NY, CA and other states plan for reopening as coronavirus crisis eases ( ...