• 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...
  • 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 ...
  • RAPS AnnouncementsRAPS AnnouncementsRAPSRAPS' Latest

    RAPS releases updated Regulatory Competency Framework

    RAPS today announced the release of its updated Regulatory Competency Framework , describing the essential elements of what is required of regulatory professionals at four key career and professional levels. The framework is relevant to regulatory professionals in multiple healthcare product sectors, including pharmaceuticals, medical devices and biotech, and is useful to individual professionals, hiring managers and organizations. “The Regulatory Competency Framework ...
  • Regulatory NewsRegulatory News

    European Commission identifies 10 ‘promising’ COVID treatments

    The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.   A panel of scientific experts selected the 10 drugs from a pool of 82 therapeutic candidates that are in late-stage clinical development.    “In selecting the 10 most promising candidates, experts focused on the product categories with the highest potential impact on the pandemic: produc...
  • RAPS AnnouncementsRAPS AnnouncementsRAPSRAPS' Latest

    Global regulatory workforce nearly 100K, says new report from RAPS, Elemed

    Nearly 100,000 professionals around the world currently work in the field of regulatory affairs for healthcare products, such as pharmaceuticals, medical devices, and biotechnology products, including vaccines. This is according to a new joint report from RAPS and Elemed , a leading technical recruiter specializing in regulatory affairs. The Global Regulatory Affairs Professionals Workforce report, previewed this week at the RAPS Convergence 2021 virtual conference...
  • Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • RoundupsRoundups

    Euro Roundup: EU launches survey for COVID-19 drug developers

    The EU is holding a survey to understand the needs of companies developing new and repurposed treatments for COVID-19. The follows the European Commission’s recent strategy to support the approval of up to five new COVID-19 drugs by the end of the year.   (RELATED: EC strategy aims for 3-5 new COVID therapeutics by year end , Regulatory Focus 6 May 2021)   In the survey, the EU asks for information about the COVID-19 therapies companies are developing, includi...
  • Regulatory NewsRegulatory News

    IVDR: MDCG charts rollout in new implementation plan

    The European Commission’s Medical Device Coordination Group (MDCG) this week released its joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR) set to take effect next May.   With the date of application of the Medical Devices Regulation (MDR) now in the rear view, MDCG’s attention is turned to challenges on the horizon related to IVDR. MDCG previously released a joint implementation plan for MDR in March 2020, bef...
  • RoundupsRoundups

    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...