{"product_id":"drug-development-and-fda-regulations-2026-12-16","title":"Drug Development and FDA Regulations","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e \u003cp\u003eThis course provides an overview of the drug development process including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) processes. It is ideal for early stage investigators from varied disciplines and new industry professionals with a need to develop an understanding of the drug development process. The course will review the steps that lead up to the clinical trial process. It will discuss the phases of clinical development that are part of the IND (the actual human trials that are conducted to demonstrate safety and efficacy to allow the regulatory authorities reason to approve the investigational drug for marketing). The NDA process will then be reviewed with insight into possible post-NDA activities that may be requested. The included workbook is a great tool for reference purposes.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss the FDA's role in drug development\u003c\/li\u003e \u003cli\u003eExplain the logic of the drug development process\u003c\/li\u003e \u003cli\u003eCite the basics of non-clinical drug testing\u003c\/li\u003e \u003cli\u003eDiscuss briefly the requirements for an IND\u003c\/li\u003e \u003cli\u003eCite the basics of clinical trial structure and design, including Phase 1, 2, and 3 clinical trials\u003c\/li\u003e \u003cli\u003eDiscuss briefly the requirements for an NDA\u003c\/li\u003e \u003cli\u003eExplain briefly the post approval responsibilities of sponsors, including Phase 4 clinical trials\u003c\/li\u003e \u003cli\u003eDescribe the fundamentals of GLP, GCP, and GMP\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eInvestigators\u003c\/li\u003e \u003cli\u003eSite Study Team Members\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eNew industry professionals with a need to understand the drug development process\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eInstructor\u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors:\u003c\/p\u003e \u003cp\u003eGary B. Freeman, M.S.\u003c\/p\u003e \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 biographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e \u003cp class=\"bold-italic\"\u003eDay One: 8:30 a.m. - 5:00 p.m.\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eIntroduction\u003c\/span\u003e\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eFDA's Role in Drug Development\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eLogic of Drug Development\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eBasics of non-clinical drug testing\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eRequirements for an IND\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eBasics of clinical trial structure and design (Phase 1, 2, 3 clinical trials)\u003c\/span\u003e\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eRequirements for an NDA\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003ePost approval responsibilities of sponsor (Phase 4 clinical trial)\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003e\u003cspan\u003eFundamentals of GLP, GCP and GMP\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eDrug Development Process\u003c\/li\u003e \u003cli\u003eReview of Form FDA 1571 for an IND application\u003c\/li\u003e \u003cli\u003eReview of Form FDA 1572 for conducting a clinical trial\u003c\/li\u003e \u003cli\u003eReview of Form FDA 356h for an NDA application\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e \u003cp\u003eRegistration fees include assorted breakfast items that will be available each day 1\/2 hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e \u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. \u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\"\u003e\u003cspan\u003eClick here for our seminar cancellation policy\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\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 7 hours (0.7 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#: 0778-0000-19-003-L01-P. Released: 5\/19. \u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003e \u003c\/p\u003e \u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/span\u003e\u003cb\u003e\u003cspan\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375366168941,"sku":"BI17593","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/drug-development-and-fda-regulations-2026-12-16","provider":"Barnett International ","version":"1.0","type":"link"}