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  • Feature ArticlesFeature Articles

    Communicating the Importance of Regulatory to Various Stakeholders

    This article focuses on the importance of a strong regulatory compliant culture within an organization and proclaims that without the support and involvement of various stakeholders, it is impossible to reach and maintain this culture. The author explains how regulatory professionals can effectively communicate the importance of regulatory to help the organization meet its goals.   Introduction   “How much will it cost?” is one of the first questions asked by compa...
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    Demonstrating Regulatory Value

    This article discusses the critical role of regulatory and highlights the value regulatory professionals bring to an organization in terms of their contribution to cost savings and eventual product earnings.   Introduction   In the current economic environment, biopharmaceutical sponsors are being asked to achieve more with less resources. The critical role of regulatory needs to be highlighted in terms of their contribution to cost savings and eventual product ear...
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    Estimating the Probability of Regulatory Registration Success

    This article discusses how to estimate the probability of regulatory/registration success for pharmaceutical products in development. The authors define the factors and methods used to assess regulatory/registration success and offer objective and data-driven methods to define probabilities for the purposes of documenting specific factors and/or risks relative to a likelihood of success. They provide a case study demonstrating how to use data and make estimate adjustments ...
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    The Changing Role of the Regulatory Professional

    This article discusses the widening range of responsibility for regulatory professionals and the increasing importance of their role to an organization’s bottom line. The author covers the value of continuously developing new skills in addition to regulatory and scientific knowledge to more effectively interface with colleagues with a variety of expertise. She highlights the effects of increased regulatory scrutiny, such as through compliance with the European Union’s new ...
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    How the Role of Regulatory Operations Professionals Will Evolve in the new Decade

    This article introduces forward-looking trends that may affect how the role of regulatory operations professionals will progress over the next 10 years. Regulatory operations professionals from three biopharmaceutical companies also share their perspectives on the changing regulatory landscape and emerging challenges.   Introduction   Regulatory operations professionals face a much different world from the one they did 10 years ago, as novel therapy development inc...
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    Writing Informed Consent Documents: A Balancing Act

    This article describes the best practices used to develop informed consent documents including skillful writing to communicate the objectives, benefits, implications, risks and inconveniences of participating in the clinical trial, as well as the rights as clinical trial participants. The author covers the important aspects a medical writer can contribute to developing a strong and easily understandable informed consent, including paying particular attention to using plain...
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    Why Understanding Regulatory Affairs is Important to key Company Decision Makers

    This article discusses the reasons why continuous evaluation of the regulatory framework is important for company decision makers and how companies that make efforts to understand the regulatory landscape for their product benefit.   Introduction   The life science industry is one of the most heavily regulated industries. Executives, senior managers and investors must understand how different decisions about a product can impact its regulatory path and how this aff...
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    Economic Operators: Roles and Obligations Under EU’s MDR

    Regulatory and legal experts share their views on the European Union’s revised Medical Device Regulation ( MDR ) and the EU’s requirements for Economic Operators (EOs) to play major roles in medical device authorizations and postauthorization monitoring. The article also highlights roles and responsibilities for Manufacturers, Authorized Representatives, Importers and Distributors (MAID) for assuring compliance with new EU MDR in addition to public health/patient safet...
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    Changing Regulatory Landscape, Strategy and Global Policy

    January feature articles explored the vital role of regulatory within organizations and throughout the product lifecycle. Some of the leading experts in the profession have come together to share their valuable experience on a wide range of issues impacting regulatory professionals today, including regulatory leadership for a culture of quality, how to successfully hire and engage consultants, regulatory’s role in business strategies and UDI and recall management. Other ar...
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    Regulatory Affairs Consultants: Who Needs Them and Why

    This article discusses employing regulatory affairs consultants and offers advice on who needs consultants and why, the “dos and don’ts” of finding, managing and maintaining consultants, how to choose the right consultant with the right background and expertise for the needed tasks and consultant service and pricing models. This article was adapted from a RAPS Convergence presentation held in Philadelphia 21-24 September 2019.   Introduction   The advent of today’s...
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    [Updated] The Changing Regulatory Landscape for Insulin

    This article discusses the rising price of insulin and its historical context. The authors review and analyze legislative efforts to keep prices reasonable for patients and review the various barriers to making insulin less expensive. They conclude by looking at the potential effects of regulatory changes by FDA to transition insulin from regulation under the Federal Food, Drug and Cosmetic Act ( FD&C Act ) to the Public Health Service Act ( PHS Act ),* and suggest tha...
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    Drug Development Process for Biologics: Regulatory Expectations

    This article discusses various elements involved in “upstream” and “downstream” manufacturing processes for biologic drug development and the importance of their unification. The author elaborates on the complexity and sensitivities inherent in biologics and emphasizes safety considerations. Regulatory expectations for biologics development and approval are highlighted. This article relates specifically to the EU regulatory environment.   Introduction   The develop...