{"title":"Writing and Maintaining the EU CTA (Clinical Trial Authorization)","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe\n Regulatory Affairs department must prepare documents that inform European\n    Regulatory Agencies about the proposed development plan; submit a Clinical\n    Trial Authorization (CTA) to initiate human clinical trials; answer questions\n    about on-going investigations; and construct and submit any updates to the CTA\n    in a concise and informative manner. Regulatory submissions are more than just\n    writing – they encompass strategy, research, writing, organizing and leading a\n    team, compiling, editing, publishing, and tracking of the information. When\n    initiating a global clinical trial program, many moving parts need to be\n    brought into harmony to ensure compliance and that timelines are met. Attendees\n    will walk away with tools to help plan, write, and manage multiple CTAs with\n    all their differing requirements. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eNavigate Europe’s regulations, directives, and\n        guidelines\u003c\/li\u003e\n\u003cli\u003eDescribe the basic requirements of\n        the CTA, the Investigational New Drug (IND) equivalent in the EU\u003c\/li\u003e\n\u003cli\u003eIdentify the key documents that will\n        be needed for the preparation of each country’s CTA\u003c\/li\u003e\n\u003cli\u003eIdentify the documents required by\n        each country to support the CTA\u003c\/li\u003e\n\u003cli\u003eDetermine the timelines for review\n        by Ministry of Health and Ethics Committees\u003c\/li\u003e\n\u003cli\u003eDetermine what is needed to amend\n        and maintain the CTA including safety and annual reports\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eRegulatory Associates and Managers\u003c\/li\u003e\n\u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e\n\u003cli\u003eManufacturing Personnel\u003c\/li\u003e\n\u003cli\u003eClinical Research Professionals\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003ePre-Clinical Personnel\u003c\/li\u003e\n\u003cli\u003eOther Members of the Drug\n        Development Team who wish to know more about the global drug development\n        and CTA submission process\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eJoy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S, F.R.A.C.P. \u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer\n                    biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835\u003c\/p\u003e\u003cp\u003eIncludes up to 20\n        participants at one site. All participants (up to 20) are eligible for\n        “Certificates of Attendance,” and accreditation, provided that accreditation\n        requirements are met. For groups larger than 20 or for additional sites, please\n        call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the\n        Accreditation Council for Pharmacy Education as a provider of continuing\n        pharmacy education.  Participants will\n        receive 3 hours (0.3 CEUs) of continuing education credit for full\n        participation, including the completion of a pre-test, post-test, and program\n        evaluation.  Barnett International will\n        issue a receipt of completion for earned CEUs within three weeks of program\n        completion.  ACPE#: 0778-0000-17-055-L01-P.\n        Released: 5\/17. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\n this course at your company! For more information, contact Naila Ganatra at +1\n            215.413.2471.  \u003c\/span\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/writing-and-maintaining-the-eu-cta-clinical-trial-authorization.oembed","provider":"Barnett International ","version":"1.0","type":"link"}