{"title":"EU Clinical Trial Regulation 536\/2014: Are You Ready?","description":"\u003cp\u003e\u003cimg title=\"Course Description\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/CourseDescription.jpg?n=5553\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cspan style=\"line-height: 1.5em; font-family: Verdana; font-size: 12px;\"\u003eThe effective date for the implementation of the European Union (EU) Clinical Trial Regulation of 2014, which establishes the rules for conducting clinical trials throughout the EU, is rapidly approaching. The regulation ensures that Member States, in authorizing and supervising the conduct of a clinical trial, adhere to ‘one set of rules’. The regulation also brings harmonization with the ICH GCP E6 Guideline R2 proposed addendum of 2015, various draft and final European Medicines Agency (EMA) Reflection Papers (e.g., risk-based quality management, Trial Master File and Archiving), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) serious breaches reporting requirements. In this web seminar, the instructor systematically presents select regulation requirements so learners will be able to swiftly, efficiently, and effectively perform an internal review and gap analysis of their organization’s procedures, processes and personnel training in order to be ‘ready’ by the effective implementation date. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" style=\"line-height: 1.5em;\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/LearningObjectives.jpg?n=4499\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDistinguish between the EU Clinical Trial Regulation and the EU Clinical Directive\u003c\/li\u003e\n\u003cli\u003eDescribe the EU Clinical Trial Regulation requirements for Sponsors, CROs, Investigators, Member States and Independent Ethics Committees\u003c\/li\u003e\n\u003cli\u003eIdentify organizational practices requiring implementation or modification to ensure compliance by the effective date\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/WhoShouldAttend.jpg?n=7655\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eManagers\/Directors: Clinical Operations, Quality Management, Compliance, Process Improvement, Quality Assurance\u003c\/li\u003e\n\u003cli\u003eStudy Managers\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eInvestigators\u003c\/li\u003e\n\u003cli\u003eStudy Coordinators\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/Instructor.jpg?n=9798\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eLiz Wool, R.N., B.S.N., C.C.R.A., CMT\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cfont color=\"#800080\"\u003eClick here for complete trainer biographies\u003c\/font\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Registration Fees\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/RegistrationFees.jpg?n=5717\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e$795\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eIncludes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Accreditation Information\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/AccreditationInformation.jpg?n=3445\" border=\"0\"\u003e\u003cbr\u003e\u003cbr\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-16-019-L01-P. Released: 3\/16. \u003c\/p\u003e\n\u003cp align=\"center\" class=\"Abstract\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eHold this course at your company! \u003c\/strong\u003e\u003cstrong\u003eFor more information, contact Naila Ganatra at \u003c\/strong\u003e\u003c\/font\u003e\u003cspan style=\"text-align: left;\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003e+1 215.413.2471.\u003c\/strong\u003e\u003c\/font\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/eu-clinical-trial-regulation-536-2014-are-you-ready.oembed","provider":"Barnett International ","version":"1.0","type":"link"}