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    Hear from the experts who wrote the book

    RAPS has introduced a new, comprehensive resource that promises to find a secure place on every regulatory professional’s bookshelf. Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition , spans 18 chapters with updates from more than 30 leading regulatory experts. Topics range from why it is no longer enough for today’s regulatory professional to just focus on regulatory guidance, to a primer on regulatory intelligence, to defining regulatory strategies...
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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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    Is your software a medical device?

    Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, based on presentations from RAPS Regulatory Convergence, October 2018, explores whether and when computer software, used in a variety of ways in healthcare is a medical device. 1 The author reports on recent software and application regulations in both the European Union where...
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    Unifying the Clinical Landscape to Drive Efficiency and Compliance

    This interview with Terry Murphy, Vice President of Janssen Research and Development, describes problems experienced with the company’s critical technologies for conducting global clinical trials, how the decision was made to replace them and what new technologies were implemented. Murphy reviews the benefits gained after the replacement was completed and also explains how the company maintains data security while they are “watching the marketplace and the evolution of te...
  • Global Opportunities and Requirements for Expedited Pathways

    This interview features insight from two leading industry executives, Bridget Heelan and Bhardwaj (Bob) Desai , on the complexities of expedited pathways in the major markets of the US, EU and Japan and highlights expedited pathways with regard to significant benefit, clinical trials design and data, surrogate end points, orphan drugs, reimbursement and potential drawbacks to expedited pathways. Introduction Because of increased research and drug development ...
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    Expanded Access Programs: Making Compassion Work

    This article discusses issues and efforts related to expanded access programs aimed at providing patients with quicker access to new and experimental drugs, many of which are potentially lifesaving. The perspectives of health authorities, industry and patients are explored as well as the historical legal and ethical issues involved in ensuring expanded access drugs are safe and efficacious. Introduction In the late 1980s and early 1990s, the HIV/AIDS emergency prompted ...
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    Re-Designing Regulatory Capabilities

    Faced with growing regulatory burdens, Bristol Myers Squibb (BMS) and Halozyme each committed time and resources to connect regulatory functions from end-to-end with the goal of improving efficiency and transparency. This article describes how two very different companies made their business case, streamlined processes and managed change. The article also provides elements of what the two companies learned along the way. Introduction Life sciences companies are driving ...
  • Feature ArticlesFeature Articles

    Re-Designing Regulatory Capabilities

    Faced with growing regulatory burdens, Bristol Myers Squibb (BMS) and Halozyme each committed time and resources to connect regulatory functions from end-to-end with the goal of improving efficiency and transparency. This article describes how two very different companies made their business case, streamlined processes and managed change. The article also provides elements of what the two companies learned along the way. Introduction Life sciences companies are driving ...
  • Feature ArticlesFeature Articles

    Responding to the Challenges of Meeting the New EU Regulations Requirements: Insight from Three Global Regulatory Executives

    This article describes efforts to prepare Cook Medical and its partners for full implementation of European Union Medical Device Regulations in (EU-MDR) in 2020. It is based on interviews with Cook executives Jennifer Kerr, president of Cook Research Incorporated (CRI), April Lavender, senior vice president of regulatory affairs for Cook Medical, and Sinead Quaid, director, global regulatory affairs, at Cook Ireland. Introduction With the European Parliament's final app...
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    Implementing the New EU Medical Devices Regulations

    This article discusses the steps toward implementing the new EU regulations on medical devices with a focus on better pre-market control, establishing oversight and data systems. It is based on a presentation given by Salvatore Scalzo at the RAPS EU Regulatory Essentials Workshop held in Brussels, Belgium in July 2017. Introduction Provisions related to the European Union's (EU) medical devices legislation are currently explained in three directives. Directive 90/385...