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  • 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...
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    Veterinary Borderline Products, Veterinary Medical Devices and In Vitro Diagnostics: Global Regulatory Overview

    This article presents the regulatory framework for veterinary medical devices including examples and related guidelines for manufacturers and distributors within Europe and territories in Switzerland and the UK. It is a follow up to “US and EU Veterinary Medical Device Regulation.” 1 Introduction The previous article described regulatory efforts related to veterinary medical devices in the US and EU. It explored a small, descriptive sample of veterinary medical dev...
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    US and EU Veterinary Medical Device Regulation

    This article describes regulatory efforts applied to veterinary medical devices in the US and EU and explores a small, descriptive sample of veterinary medical devices available on the US market to stimulate growth, innovation and dissemination throughout Europe. Introduction The effects of drugs and medical treatment in animals may vary from drug-to-drug and from species-to- species because of physiological and other species differences. In addition, the effectiveness ...
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    eCTD: A Global Regulatory Overview

    This article outlines the global status of electronic Common Technical Document (eCTD) and its implementation impact on companies. The author provides an international overview and focuses on regulatory eCTD submission requirements and global harmonization for medicinal products for human use in Canada, Europe, Japan and the US. Tips for organizing common technical documents are included. Introduction The electronic Common Technical Document (eCTD) is an international s...
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    Impact of the Revised EU Clinical Trial Regulation

    Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulat...