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  • RAPS AnnouncementsRAPS Announcements
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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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    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...
  • Regulatory NewsRegulatory News

    EMA Staff Losses Tick Up as Workload Increases

    As the interim arrangements to allow European Medicines Agency (EMA) staff to telework from London have now ended, the agency said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London. “Due to these ongoing resource constraints, delivery of EMA’s work programme for Q4 2019 will be challenging for the Agency, particularly in view of the need to implement new legislation for veterinary medicines and medic...
  • Regulatory NewsRegulatory News

    Industry, Advocacy Groups Seek Clarity on Proposed Changes to Informed Consent Rules

    Trade associations representing the medical device and clinical research industries, as well as the nonprofit public advocacy organization Public Citizen, are calling for the US Food and Drug Administration (FDA) to clarify provisions of its proposed rule for institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.   Background   Under current FDA regulations...
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    RAPS Opens Board of Directors Nominations

    Today, RAPS opened the call for nominations for three vacant positions on the 2020–22 term of its board of directors. RAPS is seeking qualified candidates to fill the roles of president-elect, treasurer and one director position. Nominations will be accepted now through 29 March. Nominees should be distinguished and experienced regulatory leaders with a strong desire to play an active role in advancing and supporting the profession. To be considered, candidates must be R...
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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...
  • Regulatory NewsRegulatory News

    FDA, HHS Finalize Guidance on Documenting IRB Activities

    The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities. The guidance, developed jointly by the two agencies, details how and what IRBs should document in the meeting minutes they are required to keep under 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2), which include: Attendance at the me...
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    RAPS Announces Board President-Elect and New Directors Slate

    • 05 June 2017
    Following careful review of all nominations for open positions on the RAPS board of directors 2018–2020 term, the RAPS nominating committee announced the slate of officers and directors to join the board for its next term. Following are the incoming board members: President-elect: Glenn Byrd, MBA, RAC Senior Director, Promotional Regulatory Affairs AstraZeneca Directors: Raina Dauria, MS, RAC Senior Director, Regulatory Affairs Ethicon Inc., ...
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    FDA Science Board Weighs Plan for 'Cures' Funds

    The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act . Last week, FDA released its proposal for how it would spend the funds ahead of Tuesday’s meeting, with the bulk of the funds to be devoted to sections of the law on "Advancing New Drug Therapies" and "Patient Access to Therapies and Information."...
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    RAPS Seeks Board Nominations

    RAPS has begun the nomination process for openings for the 2018–2020 term of its board of directors , and is now accepting nominations for president-elect and up to four director positions. Nominees must be active RAPS members in good standing, and all completed nominations applications and supporting materials are due 31 March . For more information visit: Board of Directors Nomination Process . At least two letters in support of the nomination should be ema...
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    RAPS' New Board of Directors Begins 2017 Term

    The 2017 term for the RAPS board of directors of began officially on 1 January. For the new term, Todd Chermak of Abbott Established Pharmaceuticals takes over as chairman. “I am extremely proud to serve as chairman of the RAPS board of directors,” said Chermak. “RAPS plays an important role in helping regulatory professionals effectively perform their critically important jobs and in promoting regulatory excellence at all levels. I look forward to playing a key r...
  • Regulatory NewsRegulatory News

    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...