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  • Feature ArticlesFeature Articles

    Responding to Serious or Persistent Noncompliance

    This article identifies some root causes of serious and continuing noncompliance and describes the Professionalism and Integrity (PI) in Research Program, a first-of-its-kind nonprofit educational program developed to remediate noncompliance. By describing the evidence-based goals and curricular strategies developed by one program, this article offers regulatory professionals not only a training referral option, but a variety of issues to consider when developing action pl...
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    Key Concepts to Enhance Regulatory Communication and Ethics in the Current Environment

    This article discusses the current regulatory environment and presents several ideas for enhancing communication among regulatory and cross-functional teams. The author presents three key concepts for achieving this, including the flow of knowledge and information, senior regulatory presence with minimal hierarchy and applying appropriate regulatory strategies for achieving timely approvals and cites RAPS core values for maintaining regulatory ethics.   Introduction ...
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    Improving Communication with Health Authorities Throughout the eCTD Submission Process

    This article discusses the benefits of understanding the role of regulatory operations and facilitating proper internal team communication with regulatory affairs to support efficient and clear communication with health authorities through the eCTD submission process. The author highlights steps and procedures to improve both understanding and carrying out the submissions process. Topics include PDF processing, metadata, hyperlinks quality control and more.   Introduct...
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    Apostille and Consular Legalization: Critically Important, Often Overlooked

    This article discusses document authentication processes often required when companies export goods internationally with a focus on corporate documents. The author provides case studies to help clarify procedures.   Document Authentication 101   In the US, companies are required to have specific documents authenticated before they are able sell products in international markets. Depending on the destination country for the product(s), the authentication process is ...
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    Preparing for High-Stakes Regulatory Meetings in the US and Europe

    This article provides regulatory professionals with an understanding of the specifics of FDA Advisory Committee (ADCOM) and Committee for Medicinal Products for Human Use (CHMP) Oral Explanation (OE) meetings. The authors outline key guiding principles to help regulatory teams more effectively structure their preparation timelines, bring focus to their pre-meeting work and ensure they perform well on meeting day.   The article is based on a presentation by the authors ...
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    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...
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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...