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...

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 ...

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...

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...

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 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 ...

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 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...

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...

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...

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...

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...