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    RAPS announces board slate; Cooper, Salditt to serve second terms

    The RAPS nominating committee has selected the slate of new members set to join the board for the term beginning 1 January 2022, following careful review of all nominations for two open director positions. Following are the two incoming directors: Carol Cooper , MS, RAC, IM(ASCP), RM(AAM), principal, CM Cooper and Associates Diana Salditt , FRAPS, independent regulatory advisor, (formerly) senior program director, Medtronic  Both Cooper and Salditt are current fi...
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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 recognizes new Fellows, Creaven-Capasso, Drago and McKeen

    RAPS has announced the three outstanding senior regulatory professionals comprising the 2020 class of RAPS Fellows . The honor of being a RAPS Fellow is reserved for seasoned, proven leaders, who thrive on building and sharing regulatory knowledge that shapes the future of the profession. New Fellows are selected annually and recognized in conjunction with RAPS Convergence , the largest annual conference for the global healthcare regulatory community. This year’s event w...
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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...
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    RAPS announces slate of incoming board members

    After reviewing all nominations for the four open director positions on the RAPS board of directors for its next term, the RAPS nominating committee has selected the slate of new members set to join the board for the 2021–2022 term. Following are the four incoming board members: Kimberly Belsky, MS, executive director, regulatory policy and intelligence, Mallinckrodt Pharmaceuticals Lawrence Liberti, PhD, RAC, head, regulatory collaborations, Centre for Innovation in R...
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    RAPS seeks 2020 Fellows applications

    If you have done tremendous work within the regulatory profession, RAPS invites you to apply for the 2020 Class of RAPS Fellows . Applications will be accepted through 22 May 2020 . Selection criteria to become a RAPS Fellow include contributions to the regulatory profession, management and leadership experience, regulatory knowledge, stellar regulatory professional employment history, and pursuit of continuing education and professional development. Since 2008, th...
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    RAPS Welcomes Germany Chapter

    RAPS added another European chapter as it announced the launch of the RAPS Germany Chapter . The group began its affiliation with RAPS as a local networking group before becoming an official chapter. The addition of the Germany chapter to RAPS’ global network brings the worldwide total to 19 chapters and eight local networking groups. “In Germany as elsewhere in Europe, RAPS’ presence has been enthusiastically received, linking local regulatory professionals with their...
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    RAPS Welcomes Colorado Chapter

    RAPS has announced the official launch of the RAPS Colorado Chapter . The group first began as a RAPS-affiliated local networking group before becoming a full chapter. Chapter leaders and other representatives attended RAPS’ recent Regulatory Convergence in Philadelphia, where they were welcomed and acknowledged by RAPS Executive Director Paul Brooks. “We are so pleased to officially welcome the RAPS Colorado Chapter,” said Brooks. “RAPS chapters are a vital part of ou...
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    RAPS Honors Four New Fellows

    RAPS today honored the 2019 class of RAPS Fellows , a distinction bestowed upon seasoned regulatory leaders who have gone above and beyond to give back to the profession and share their experience and expertise with others.   “To be named a RAPS Fellow, an awardee must exhibit unique dedication to the regulatory field that is demonstrated by a history of commitment and success,” said RAPS Chairman Don Boyer, BSc, RAC, FRAP. “From a strategic leader to a dedicated ment...
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    510(k) Modernization: FDA Floats Need to Pursue New Authority

    Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was new...
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    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH). The webinar led by Maureen Dreher, policy analyst at CDRH’s Office of Device Evaluation, underscored the need for additional transparency around the Breakthrough Device Program. This request was supported across several participants during the ...
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    RAPS 2019 Board of Directors Begins Term; Don Boyer Takes Helm as Chair

    RAPS welcomed its 2019 board of directors, which officially began its term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, takes over as chairman.   “I am honored to serve as chairman of the RAPS board of directors,” said Boyer. “Throughout its history, RAPS has been instrumental in not only helping regulatory professionals do their jobs better, but also in driving awareness of the critical role the regulatory pr...