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    Euro Convergence: Experts advise on ways to manage the MDR grace period

    Medical device companies in Europe have much work to do to get their products compliant with the EU’s new Medical Device Regulation (MDR) and should not be wasting any time, asserted a panel of experts who spoke at RAPS Euro Convergence 2021 on 10 May.   At the virtual meeting, the experts gave some concrete advice for device manufacturers to ready themselves for a seamless transition.   The EU Medical Device Regulations (MDR) is a new set of new regulatory require...
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    Euro Convergence: Regulators and industry seek ‘sparks’ of European change

    The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.   The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representati...
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    Euro Convergence: Look for ‘positive sparks,’ says Klasen

    A key organizer of RAPS’ Euro Convergence 2021 speaks to what’s new this year, how the conference is approaching hot-button topics in the EU regulatory space and how first-time attendees can maximize their experience during the live, virtual event.   Eric Klasen, of Waypoint LC Consulting, is a co-chair of the RAPS Euro Convergence 2021 Conference Committee. Klasen, with co-chairs Gert Bos, executive director of Qserve Group, and Sabina Hoekstra-van den Bosch, a regula...
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    RAPS Euro Convergence: A preview

    RAPS Euro Convergence is just around the corner. The three-day conference devoted to European healthcare product regulations and regulatory issues kicks off Monday 10 May, running through 12 May. Pre-conference workshops begin Friday, 7 May.   This year’s all-virtual program will feature more than 130 expert speakers and more than 40 educational sessions. Attendees will hear from speakers representing the European Commission (EC), the European Medicines Agency (EMA),...
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    RAPS' virtual Euro Convergence 'provides needed forum' for European regulatory pros

    RAPS’ weeklong 2020 Euro Convergence wrapped up today, fittingly concluding with a session devoted to the impact of the COVID-19 pandemic on the future of regulatory. The profound effects of the pandemic have reached across myriad aspects of healthcare and regulation, forcing regulators and regulated industry to adapt and collaborate in new ways, streamline processes and work on accelerated timeframes.   Euro Convergence programming also had to adapt to suit this yea...
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    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...
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    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...
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    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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    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...
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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...