RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Euro Convergence: Looming deadlines, regulatory bottlenecks keep EU officials up at night

    The opening plenary session of the Euro Convergence 2020 virtual meeting brought together regulatory professionals from industry, notified bodies and competent authorities. The virtual format, said co-chair  Gert Bos, FRAPS of the Netherlands’ Qserve Group, meant that it was possible to draw together a record 14 individuals for the session.   Co-chair Sabina Hoekstra-van den Bosch, PharmD, FRAPS, asked session participants what is keeping them up at night in 2020, espe...
  • Feature ArticlesFeature Articles

    Making the transition from regulatory manager to regulatory consultant

    This article is about making the transition from company-based regulatory management to regulatory consultancy. It describes the differences between the two roles and provides hands-on, detailed guidance on best practices and how to prepare and tool up for consulting. The author presents a case study demonstrating step by step how a consultant drew on those practices and tools to assist an overseas client in successfully marketing an existing medical device in the US.   ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    EC’s Erik Hansson among panelists for Euro Convergence opening plenary

    Erik Hansson, the European Commission’s deputy head of devices, will be among the expert panelists kicking off RAPS’ 2020 Euro Convergence , being held live online, 26–30 October. The 26 October plenary, Global Perspectives on the 2020 Regulatory Landscape, will feature 16 regulatory experts from organizations including government agencies, notified bodies and manufacturers. Hansson leads the EC’s operational team dealing with the implementation of the EU Medical Devic...
  • Feature ArticlesFeature Articles

    US-focused regulatory toolbox: The basics

    This article examines regulatory tools found mostly on the US Food and Drug Administration’s (FDA’s) website for use by regulatory affairs professionals interested in drug products and medical devices marketed in the United States.   FDA guidance documents 1 Guidance documents represent the agency’s current thinking or interpretation of a particular policy or topic. They are an especially useful tool for RA professionals dealing with issues such as drug development ...
  • 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...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    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...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    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 ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    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...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    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...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    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...