RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    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...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    A guide to good vendor management

    This article addresses best practices for regulatory affairs departments in their work with vendors. The author provides an overview of the vendor-contract giver relationship, then discusses finding an appropriate vendor, due diligence in selecting a vendor, vendor-related risk management, contract management, performance evaluation, maintaining the vendor-contract giver relationship, and the importance of follow-up meetings, audits, and reviews.   Introduction   A...
  • Feature ArticlesFeature Articles

    Using risk management to support outsourcing activities

    This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...
  • 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

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    WHO Consults on QMS Guideline for Regulators

    The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national regulatory authorities (NRAs).   Specifically, the 96-page draft guideline is meant to fill the gaps for NRAs looking to implement a QMS based on the International Organization for Standardization’s (ISO) 9001:2015 Quality Management Systems – Requirements standard, as other existing QMS guidelines do n...
  • 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...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    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...
  • Regulatory NewsRegulatory News

    Industry Comments on ICH Product Lifecycle Management Guideline

    The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on pharmaceutical product lifecycle management.   The 31-page draft guideline , ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management , was adopted by ICH and released for public consultation last year.   Most of the comments EMA received express...
  • RAPS' LatestRAPS' Latest

    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...
  • RAPS' LatestRAPS' Latest

    Risk Management: What Regulatory Professionals Need to Know

    For companies looking to develop new therapies or improve existing ones, and for the regulators overseeing them, striking right balance between potential benefits to patients and an appropriate level of risk is critical. The drive to innovate, develop new and better products, and help patients live healthier lives has led to numerous medical breakthroughs. But it is just as imperative that products are as safe as possible, and that where there are associated risks, they a...