{"title":"EU Clinical Trial Regulation 536\/2014: Clinical Trial Applications and Amendments","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cp\u003eThis\nweb seminar reviews clinical trial applications and the EU single authorization\nprocess including Part I and Part II assessment reviews\/reports\/ determinations\nas well as the EU portal for sponsor and European Medicines Agency (EMA)\/Member\nState communications. The submission and assessment of the application by the\nReporting Member State and Concerned Member State(s), and their\nresponsibilities will be reviewed along with their assessment reports and\ncorresponding review timeline requirements. We will also examine amendments,\nsubstantial modification indications, requirements and authorization.\nAuthorization of investigational medicinal products for use in clinical trials\nwill also be discussed from the perspectives of manufacturing, importation and\nlabeling.  Insight and recommendations\nsponsors can implement to be in compliance with the EU CTR 536\/2014\nrequirements will also be covered. \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eExplain the information and language requirements\n     in a clinical trial application (CTA) dossier\u003c\/li\u003e\n\u003cli\u003eDescribe the EU single authorization\n     process\u003c\/li\u003e\n\u003cli\u003eIdentify when an\n     amendment\/substantial modification is required\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eStudy Managers\/Directors\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\n\u003cp\u003eJoy\nFrestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S. \u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003e\u003cspan\u003eClick here for complete trainer\nbiographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003e$735\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIncludes up to 20\nparticipants at one site. All participants (up to 20) are eligible for\n“Certificates of Attendance,” and accreditation, provided that accreditation\nrequirements are met. For groups larger than 20 or for additional sites, please\ncall +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eBarnett International is accredited by the\nAccreditation Council for Pharmacy Education as a provider of continuing\npharmacy education.  Participants will\nreceive 1.5 hours (0.15 CEUs) of continuing education credit for full\nparticipation, including the completion of a pre-test, post-test, and program\nevaluation.  Barnett International will\nissue a receipt of completion for earned CEUs within three weeks of program\ncompletion.  ACPE#: 0778-0000-17-064-L01-P.\nReleased: 2\/17. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold\nthis course at your company! For more information, contact Naila Ganatra at +1\n215.413.2471. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/eu-clinical-trial-regulation-536-2014-clinical-trial-applications-and-amendments.oembed","provider":"Barnett International ","version":"1.0","type":"link"}