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  • RAPS' LatestRAPS' Latest

    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

    CA Congressman Seeks More FDA Outreach for Biotech Start-Ups

    Rep. Eric Swalwell (D-CA) on Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf seeking further assistance for start-up biotechnology companies in the Bay Area. Swalwell said several companies have expressed their concerns on “the complexity and length of the regulatory process” that many do not have the resources to navigate. He also said the companies are seeking a local San Francisco Bay Area FDA office to provide face-to-fac...
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    Regulatory Convergence Preview: Regulation and Innovation

    RAPS will bring the largest annual gathering of the global healthcare regulatory profession to San Jose, CA, 17–20 September . The 2016 Regulatory Convergence will take place at the San Jose McEnery Convention Center. The Convergence is expected to draw more than 2,000 participants, including healthcare product regulators, scientists, researchers and regulatory professionals from life sciences companies. This year marks RAPS’ 40th anniversary, and the Converg...
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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' First Chapter Celebrates 25 Years

    As head of the RAPS Bay Area Chapter , Shaalini Doan is eager to welcome RAPS members to San Jose, CA, for the upcoming annual gathering of the global regulatory profession. “The Bay Area is the perfect place to host the 2016 Regulatory Convergence , especially since this year we have the chance to celebrate two significant milestones—the 25th anniversary of our local chapter along with the 40th anniversary of RAPS!” The Bay Area Chapter is the original l...
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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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    Disruptive Technologies Expert Ray Wang to Keynote Regulatory Convergence in San Jose, CA

    R “Ray” Wang, principal analyst, founder, and chairman of Silicon Valley-based Constellation Research will deliver the opening keynote Sunday evening, 18 September, at RAPS’ 2016 Regulatory Convergence conference in San Jose, CA. The Convergence, the largest annual gathering of healthcare product regulatory professionals, will be held at the San Jose Convention Center 17–20 September. Wang works with Global 2000 companies on areas including innovation, busines...
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    The Art of Saying Yes and No

    ‘Yes’ and ‘no’ are two simple words in the English language, but they generate a vast array of mind-boggling complexities when used incorrectly—whether intentionally or unintentionally. How many of us have said yes when we actually wanted to say—or should have said—no, and vice versa? Imagine you are invited to party you have no desire to attend, and inside you are screaming “no,” but you say yes because you do not want to offend the host or wish others to think y...
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    RAPS to Host San Jose Career Fair

    On 10 September, RAPS will host a career fair and networking event for regulatory job seekers and employers in the San Jose area. The event will be held from 5:30 to 8:30 pm PDT at the Biltmore Hotel & Suites in Santa Clara, CA, and will give attendees a chance to network and meet in person to discuss open regulatory positions and career opportunities. The career fair is free for job seekers to attend. To register, fill out this online form . Employers int...
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    Embracing Change in EU Medical Device Regulation: The Notified Body Perspective

    The RAPS San Francisco Bay Area Chapter kicked off 2014 with a 7 March conference focused on the proposed EU medical device regulations. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. The message was clear-change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. A BSI Healthcare medical device expert team p...