RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    The 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 a medium-sized generic drug manufacturer’s perspective. They offer a variety of reasons, all of which point to a “broken marketplace.” The article concludes with a discussion of mitigation activities and in an epilog address the current COVID-19 pandemic, warning that drugs and active i...
  • Feature ArticlesFeature Articles

    Making the call to test in-house or outsource

    With dynamics across the medical device industry continuing to evolve, manufacturers should evaluate their current standing to ask themselves if they should perform in-house testing, outsource or a combination of both. This article discusses key considerations before making a final decision.   Introduction   Transitioning to the stringent requirements of the European Union Medical Devices Regulation ( EU MDR ) continues to pose significant hurdles for medical dev...
  • Feature ArticlesFeature Articles

    A guide to good vendor management

    This article addresses best practices for regulatory affairs departments in their work with vendors. The author provides an overview of the vendor-contract giver relationship, then discusses finding an appropriate vendor, due diligence in selecting a vendor, vendor-related risk management, contract management, performance evaluation, maintaining the vendor-contract giver relationship, and the importance of follow-up meetings, audits, and reviews.   Introduction   A...
  • Feature ArticlesFeature Articles

    Using risk management to support outsourcing activities

    This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...
  • Feature ArticlesFeature Articles

    Electronic platforms for submission of clinical trial information

    This article provides guidance for use of the European electronic platforms for retrieving and submitting information about clinical trials and compares them with other similar regional electronic databases, such as the US Food and Drug Administration’s MyStudies mobile app and Switzerland’s national platform, swissethics. The authors present an overview of some of the main international portals, available and under development, and provide an analysis of their specific as...
  • Feature ArticlesFeature Articles

    Outsourcing in regulatory operations

    This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities. Introduction The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that ti...
  • Feature ArticlesFeature Articles

    EU device regulations, COVID-19 response and global regulatory strategy

    Feature articles during April focused predominantly on the new European Medical Devices Regulation ( EU MDR ), In Vitro Diagnostic Medical Devices Regulation ( EU IVDR ) and the COVID-19 pandemic, with a number of regulatory experts examining the impact of pandemic-related delays on the progression of the European regulations. Also included were articles on the European Database on Medical Devices (Eudamed), the Mutual Recognition Agreement (MRA) between Switzerland an...
  • Feature ArticlesFeature Articles

    New claims under EU MDR and EU IVDR

    This article discusses medical device promotional and advertising product claims under Article 7 of the European Union’s new Medical Devices Regulation ( EU MDR) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR) and examines how and when product claims are misleading or false as defined under the regulations. Introduction    Article 7 of the EU MD R 1 and EU IVDR 2 provide new claims regulations for medical devices. All of the requirements relate ...
  • Feature ArticlesFeature Articles

    Preparing for EU MDR translation

    This article discusses what medical device manufacturers need to know about product information language translation as required by European Medical Devices Regulation ( EU MDR ). The author addresses how companies can better meet the regulation’s language component requirements and offers suggestions ranging from being aware of who the information reading audience is and hiring professional translators.   Introduction   The complex regulatory requirements for EU ...
  • Feature ArticlesFeature Articles

    Communication During a Pandemic

    This article offers best practices for company communication during a pandemic, such as the current COVID-19 global emergency. The author emphasizes the need to make company communications responsible and thoughtful, not only in these challenging times, but always. Discussed are best practices for communication through many mediums, such as telephone calls, email and social media and doing so in such a way that the message is not misinterpreted, misleading, sent to the wro...
  • Feature ArticlesFeature Articles

    Optimizing remote internal quality audits

    This article provides tips and techniques for effective, risk-based remote internal quality auditing methods in a good manufacturing process (GMP) quality management system. The author covers the circumstance in which a “virtual” audit may be necessary or desirable as opposed to an on-site audit and discusses potential challenges when auditing off-site and how to overcome them. She emphasizes good communication skills, discusses the characteristics of various internal audi...
  • Feature ArticlesFeature Articles

    EU IVDR changes regulatory landscape

    This article discusses new requirements for technical documentation, periodic safety reports, notified body changes, postmarket surveillance and vigilance, labeling and product traceability under the European Union’s new In Vitro Diagnostic Regulations (EU IVDR).   Introduction   Many regulatory changes are scheduled to come into effect in May 2022 as part of the new EU IVDR (2017/746.) 1 However, it likely that EU IVDR will come into effect a year later t...