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    7 Things Attendees Love About the Regulatory Convergence

    RAPS’ signature annual event, the Regulatory Convergence , is a unique opportunity for the regulatory community to gather, reconnect, examine important issues together and exchange ideas face-to-face in a setting completely dedicated to the profession. It is the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space. For many, it is the one event they prioritize above all others to attend each year. This year...
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    RAPS AnnouncementsRAPS Announcements

    MDR, IVDR and ‘Navigating the Grey’ Key Topics at RAPS Regulatory Conference Europe Opening

    The RAPS Regulatory Conference Europe 2019 kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. The EU’s transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was a key point of discussion as multiple panelists expressed concern about the ti...
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    RAPS AnnouncementsRAPS Announcements

    European and UK Health Authority Officials, Industry Leaders, Notified Body Reps, Other Experts to Speak at RAPS’ Europe Conference

    RAPS released the updated agenda for its upcoming European conference in Brussels, 13–14 May. Among the speakers for the inaugural RAPS Regulatory Conference – Europe 2019 are representatives from the European authorities, notified bodies and trade representatives, all thought leaders and stakeholders with crucial responsibilities in the effective implementation and functioning of the changing European regulatory environment. “Europe’s regulatory environment for med...
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    RAPS AnnouncementsRAPS Announcements

    RAPS Launches Europe Conference as European Regulatory Environment for Medical Products Faces Sweeping Changes

    RAPS will hold its inaugural RAPS Regulatory Conference – Europe 2019 in Brussels, 13–14 May. It comes as the European regulatory environment for medicines, medical devices and in vitro diagnostics (IVDs) is undergoing major changes, and both regulators and the regulated companies making life-saving and life-sustaining medical products face myriad uncertainties. The EU’s new Medical Device Regulation (MDR) is set to take effect next year. A new In Vitro Diagnostic Re...
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    8 Networking Tips for Regulatory Convergence Attendees

    The 2018 RAPS Regulatory Convergence at the Vancouver Convention Centre in Vancouver, BC, 1–4 October, will offer attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. At the Convergence, you will be surrounded by people who truly ‘get it.’ They understand regulatory issues, and have gathered together to examine them in depth, share ideas and meet other like-minded pr...
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    10 Ways to Get the Most From RAPS' Regulatory Convergence

    Your time is valuable. We respect and appreciate the time you take to attend the  Regulatory Convergence , and we want you to get as much out of RAPS’ signature annual event as you can. After all, it is an investment in your job, your career and your regulatory knowledge. And for those of you who may be first-time attendees, it can be particularly helpful to have an idea of what to expect. So we have a few tips to help you make the most of your Convergence experience this...
  • Regulatory NewsRegulatory News

    ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

    The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection. ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemen...
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    Prepare for the Digital Revolution, Says Convergence Keynote Speaker Ray Wang

    When the 2016 Regulatory Convergence begins next month in San Jose, R “Ray” Wang , principal analyst, founder, and chairman of Silicon Valley-based Constellation Research, will kick things off Sunday evening, 18 September, with opening keynote remarks. Wang is a noted Silicon Valley strategic thinker with expertise in areas including technology and innovation, digital disruption, business model design, engagement strategies and customer experience. He also starte...
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    RAPS Members on the Value of Regulatory Convergence

    RAPS’ Regulatory Convergence is the world’s largest annual gathering for the healthcare product regulatory profession, and this year will be held 17–20 September in San Jose, CA. Speakers and attendees come from all over the world to learn, network and exchange ideas. We recently asked a number of RAPS members at various stages of their regulatory careers about the value of attending the Convergence, and here’s what they had to say: “Regulatory Convergence is...
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    Bay Area Regulatory Pros Looking Forward to Convergence's Return to San Jose

    The Regulatory Convergence will return to San Jose, CA, in 2016, bringing RAPS’ signature annual event back not only to one of the world’s premier centers of technology and innovation—Silicon Valley—but also to the home of RAPS’ oldest and one of its most active chapters, the San Francisco Bay Area Chapter. RAPS asked some of the local chapter’s volunteers and other local regulatory professionals about what makes the San Francisco Bay Area such a special place, an...
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    Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators

    The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...
  • Regulatory NewsRegulatory News

    ICH Genomic Sampling Guidance: FDA Begins Consultation

    The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling. Specifically, the guideline, E18 Genomic Sampling and Management of Genomic Data , seeks to create uniform standards for collecting, storing and handling genomic samples used in clinical trials. According to ICH, the guideline "will clarify points to consider ...