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  • RAPS AnnouncementsRAPS Announcements
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    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 ...
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    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...
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    New method to an old approach: A semiquantitative approach for determining probability of regulatory success for ASEAN markets

    An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...
  • Regulatory NewsRegulatory News

    CDER regulatory science division touts 2020 accomplishments

    In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year.   “2020 was a challenging year. In addition to adjusting to new work environments related to the COVID-19 pandemic that involved 100% teleworking for some staff and laboratory wo...
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    April’s Regulatory Focus: Professional and career development

    Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Other articles examined communication – one on persuasive skills, another on dissemin...
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    Evolution of the regulatory intelligence profession

    Regulatory intelligence has gained significant importance with increasingly global considerations for product development, clinical trials, and submissions to ensure market access in key regions. The regulatory intelligence profession, tasked with providing strategic input to ensure regulatory compliance, has evolved to fulfill the additional needs of various departments within the company and by senior leadership by strategically analyzing relevant regulations and product...
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    The regulatory profession by the numbers: RAPS’ 2020 compensation and scope of practice survey

    The RAPS 2020 Global Compensation & Scope of Practice Report for the Regulatory Profession presents an analysis of nearly 2,000 responses from regulatory professionals from around the world who participated in an online survey in April 2020. The following article reviews the main findings from the 2020 report, focusing on regulatory professionals’ levels of education and certification, experience, the most common regulatory functions performed, and career and job motivatio...
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    Value of an RA qualification in continuous professional development and career progression

    Continuous professional development (CPD) is important for employee personal development and is of strategic value for organizations. Having qualified and knowledgeable personnel can help deploy strategy and yield competitive advantage in the marketplace. This article presents the results of a qualitative and quantitative study on the progression and experiences of industry-based graduates who completed a masters in regulatory affairs. The results demonstrate that regulato...
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    Communication of regulatory intelligence: A survey of the medical device industry

    Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets, where medical device regulations can change rapidly or be confusing and even contradictory. Understanding how, when, and with whom to communicate the new or changing regulatory information within a medical device company affects global market strategy and product success. The research reported here examined how medical device companies structure their regulatory i...
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    Regulatory Intelligence 101 authors stress importance of actionable info, communications, creativity

    RAPS recently brought together three leading authors of the just-released, newly revised third edition of Regulatory Intelligence 101 to discuss the book and the practice of regulatory intelligence (RI). Author and global RI expert, Céline Rodier Seguy, joined lead editors, Daanish Ashraf and Bill Sietsema to answer questions and provide insight on keeping up with complex and constantly changing regulatory information, during a live webcast moderated by RAPS Senior Edi...
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    March's Regulatory Focus: Regulatory intelligence

    Feature articles during March focused on regulatory intelligence (RI), including first-hand accounts of setting up a dedicated process for RI monitoring and developing an in-house RI database, as well as an examination of the implications of the US Food and Drug Administration’s (FDA’s) new integrated review template for RI. Also included were articles on the importance a global unique device identification (UDI) system, the FDA’s Bad Ad program, and the importance of writ...