{"product_id":"managing-phase-i-clinical-trials-2027-01-12","title":"Managing Phase I Clinical Trials","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003ePhase I clinical trials aim to determine the safety, tolerability and pharmacokinetics (PK) of a compound. This web seminar will explore the challenges of developing Phase 1 clinical study protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and complexity, especially in trials that involve early-phase drug metabolism, imaging and interventional procedures. Key factors to consider when developing protocols and techniques to minimize complexity while ensuring trial success will also be discussed.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eUnderstand the FDA requirements for Phase I clinical trials and review the different Phase I trial designs\u003c\/li\u003e \u003cli\u003eDiscuss challenges with early phase studies for Sponsors, Contract Research Organizations (CROs), third-party vendors and sites\u003c\/li\u003e \u003cli\u003eDiscuss how to optimize protocol design for a special population\u003c\/li\u003e \u003cli\u003eIdentify risks in early phase clinical trials and mitigation strategies\u003c\/li\u003e \u003cli\u003eAddress strategic planning and budgetary considerations for Phase I designs\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Operations and Clinical Research Associates\u003c\/li\u003e \u003cli\u003eMedical Affairs Specialists and Leaders\u003c\/li\u003e \u003cli\u003eProject Managers\/Team Leaders\u003c\/li\u003e \u003cli\u003eNew Clinical or other Project Team Leaders who will be managing projects\u003c\/li\u003e \u003cli\u003ePhysician Investigators and Coordinators\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eQuality Assurance\/Control (QA\/QC) Professionals\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eMarina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"\/pages\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 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#: 0778-0000-25-011-L99-P. Released: 1\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375364825453,"sku":"BI17622","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/managing-phase-i-clinical-trials-2027-01-12","provider":"Barnett International ","version":"1.0","type":"link"}