• RF Quarterly

    The ICH over the last 30 years: A personal reflection

    This article gives a personal reflection on the development of ICH since its inception in 1990 and during which time the author was involved both as a regulator and, more recently, an industry participant. The evolution of ICH is discussed as it has moved from an international organization involving three regions to a truly global body. The successes and the challenges are discussed, and consideration is given to future development.   Keywords – international harmo...
  • ReconRecon

    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS congratulates 108 spring RAC exam passers

    RAPS today announced that 108 professionals passed the Regulatory Affairs Certification (RAC) exams in the spring examination window, which occurred in March and April 2022. In doing so, these professionals have obtained their RAC-Drugs or RAC-Devices designation, the leading credentials for regulatory professionals in the healthcare product sector. These 108 individuals join more than 5,000 global professionals who hold RAC certifications. “On behalf of RAPS, I offe...
  • Feature ArticlesFeature Articles

    Five reasons to invest in a dedicated regulatory intelligence department

    This article presents some key points for consideration regarding the establishment of a dedicated and centralized regulatory intelligence department.   Keywords – centralized, dedicated department, regulatory intelligence   Introduction Regulatory intelligence has become an increasingly important component of regulatory affairs as the global landscape expands and changes, and professionals and businesses must adapt rapidly to remain current and viable. I...
  • RAPS AnnouncementsRAPS Announcements
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    500+ gather in Amsterdam for Euro Convergence, RAPS’ largest-ever European event

    RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years. Euro Convergence is the premier annual event for European regulatory professionals. This year’s event drew more than 500 participants from six continents and 33 countries. Attendees gathered for three days of education sessions, expert presentations and panel discussions curated exclusively by European regulato...
  • Regulatory NewsRegulatory News

    Euro Convergence: AI, notified body shortage top health authorities session

    AMSTERDAM – European healthcare product regulators should begin to focus on harmonizing guidance on artificial intelligence/machine learning (AI/ML) across regulatory regimes, according to a panel of health authority representatives at a townhall meeting at the 2022 RAPS Euro Convergence.   On 11 May, a high-level group of representatives from health authorities, notified bodies, and regulatory agencies opened themselves up for questions from delegates who asked them a...
  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Specialist vs. generalist, RI, and more

    Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an in-house regulatory database in the oncology setting, and strategic planning. Also included are articles on expedited regulatory pathway options, selecting control groups in pediatric clinical trials, and the role of artificial intelligence...
  • Feature ArticlesFeature Articles

    Strategic applications of regulatory intelligence

    Organizations require regulatory intelligence (RI) solutions now more than ever, especially in the current context of rapidly emerging technologies and evolving regulatory landscape. This article provides an overview of a three-part process of RI, consisting of data input, analysis, and output, and its strategic application in the product life cycle and business processes in achieving a competitive edge. RI has a significant range of applications and could be a practical ...
  • Feature ArticlesFeature Articles

    In-house regulatory database development: Solution for a competitive oncology landscape

    The unprecedented number of new investigational agents in clinical development in the competitive oncology space presents a significant challenge for regulatory intelligence professionals. Strategic decisions are complicated by the overwhelming amount of regulatory information scattered across numerous repositories. The development of an in-house database may facilitate success for businesses in the prevailing information-centric world. Effective implementation of an in-ho...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS Euro Convergence features speakers from EMA, FDA, and Swiss, Austrian and UK health authorities, as well as notified bodies

    Prominent officials from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), Swiss, Austrian and UK national health authorities, and several notified bodies will speak at the upcoming RAPS Euro Convergence . The annual three-day conference devoted to European healthcare product regulations and regulatory issues will take place, 10–12 May in Amsterdam. More than 120 expert speakers will provide updates and insights on important European regul...
  • Feature ArticlesFeature Articles

    The leadership role in regulatory affairs

    Abstract  The global regulatory affairs (RA) profession is facing a shift in the definition of leadership success. This article aims to shed some light on important aspects of regulatory leadership. In the context of the article, leadership is defined by the power of making a difference. It explains why critical thinking, business acumen, emotional intelligence, team building, influence and mentorship plays a vital role in building leaders and why RA professionals today...
  • Feature ArticlesFeature Articles

    Regulatory review of advertising on streaming media

    This article discusses advertising on streaming media and what regulatory reviewers need to take into consideration when reviewing online videos.   Introduction Television. One word, many meanings – it could be the wide-screen home TV, the latest Hulu-exclusive series we binge-watch on an iPad, or the 5-minute Snapchat original series that releases a new episode every week. There is no shortage of places for consumers to view video content outside of a traditional ...