• Feature ArticlesFeature Articles

    How regulatory affairs can expand its capabilities and increase diversity

    Abstract The recruitment, hiring, and training of regulatory professionals should evolve to attract and retain valuable candidates with diverse perspectives, experiences, and/or skills. Regulatory professionals may consider doing this as part of their diversity, equity, and inclusion (DEI) initiatives by hiring “hidden workers,” a term for multiple groups of people who are chronically unemployed or underemployed because of systemic problems with current workforce trainin...
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    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

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
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    Regulatory Strategies for EU MDR and EU IVDR Implementation

    September feature articles took an in-depth look at the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where global medical device leaders explored the nuances of the new requirements and answered the industry’s most challenging questions. Individual articles covered the implementation of the regulations into national legislation, what the new regulations mean for substance-based medical devices, how to incorporate clinical evaluation re...
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    Implementation of IVDR and MDR Into National Legislation

    This article discusses current revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in the European Union (EU). The authors use an example from Germany’s experience and efforts to examine revisions from an implementation perspective. The impact of this new regulatory environment and associated challenges for medical device and in vitro diagnostic device manufacturers are discussed as well as hurdles and “bottlenecks” that could m...
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    Theoretical Perspective of Technology for Regulatory Science: Part 2

    Regulatory science is the discipline that oversees, creates and implements innovation for global health needs. Yet, no philosophy of technology exists for regulatory science. This article attempts to fill that gap and focuses on problem-solving tools or 'global skills'. Introduction Part one introduced the concept of a regulatory science philosophy of technology. 1 Figure 1 depicts a regulatory science key representing the means to unlock new drug and device outcome...
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    Pharmaceutical Risk Management in the 21st Century Cures Era

    This article discusses the intersection of emerging implementation science and regulatory science innovation and how together they may advance pharmaceutical risk management in the US. The author touches on topics from implementation science, including approaching risk management as an adaptive, rapid-cycle process embedded within a learning health system; dissemination design for better adoption and sustainability of the intended risk mitigation behavior(s); and framing ...
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    Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective

    This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable fast access to market to fight emerging diseases, such as Ebola. To date, neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a vaccine or therapy for the treatment of the Ebola virus, which in Guinea, Liberia and Sierra Leone has had a case fatality rate as high as 71%. 1 Regulatory a...