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  • Feature ArticlesFeature Articles

    Global Orphan Drug Regulation

    This article discusses the criteria for and regulation of orphan designation in major global markets. The author outlines the application process and incentives for orphan designation globally with a focus on several major markets including the European Union, the US, Canada and Japan. She explains variations on the criteria for orphan drug designation in each region as well as application requirements.   Introduction   Orphan Medicinal Products (OMPs) are medicina...
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    How the Role of Regulatory Operations Professionals Will Evolve

    This article highlights the shift taking shape in the medical device and diagnostics industry and defines regulatory professionals’ increased impact on business decision-making as a result of new global regulations that require a complete regulatory transformation. This is the second in a two-part series on the evolving role of regulatory operations professionals. Introduction Regulatory operations professionals in the medical device industry have reached a crossroad...
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    Adopting Regulatory Intelligence Strategies to Foster the Evolving Landscape

    This article discusses the opportunities and challenges of creating and maintaining a regulatory intelligence program across regulated industry. The authors suggest a regulatory framework and best practice considerations to implement intelligence strategies in lieu of a standardized approach or framework.   Introduction   The pharmaceutical and medical device industries are faced with many challenges associated with the development lifecycle and overall sustainabil...
  • Feature ArticlesFeature Articles

    Adopting Regulatory Intelligence Strategies to Foster the Evolving Landscape

    This article discusses the opportunities and challenges of creating and maintaining a regulatory intelligence program across regulated industry. The authors suggest a regulatory framework and best practice considerations to implement intelligence strategies in lieu of a standardized approach or framework.   Introduction   The pharmaceutical and medical device industries are faced with many challenges associated with the development lifecycle and overall sustainability...
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    The Changing Role of Regulatory Professionals

    Regulatory Focus has brought together a diverse group of experts to address today’s most pressing issues for regulatory professionals on communication methods to employ with various stakeholders regarding why regulatory is important. Global experts provided insight and shared their experiences on the importance of regulatory affairs to key company decision makers, including what regulatory can do for all stakeholders, demonstrating regulatory value and writing informed c...
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    Regulatory and Legal Roles in Promotional Review Committee Meetings: Is there really a difference?

    This article provides perspectives on how legal and regulatory personnel and others view their roles when participating in promotional and other types of material reviews. The author defines and separates the roles and provides the results of an informal survey regarding what people in the industry think about the nature of the two roles in reference to promotional reviews. She concludes by suggesting that moving the company forward in a compliant way should be everyone’s ...
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    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...