{"title":"Drug Approval Process: Preparation and Processing of INDs and NDAs","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis\n course provides a comprehensive approach to the preparation and submission of\n    documents to the FDA for approval of drug products. Participants receive a\n    foundation of knowledge about the drug approval process, submission\n    preparation, and the underlying scientific and regulatory principles involved.\n    Guidelines for each aspect of research are provided, as well as information on\n    the structuring and assembly of INDs, NDAs, and post-approval documents.\n    Information on maintaining on-going relationships with the FDA is also\n    discussed. The course enables regulatory affairs professionals to prepare\n    concise documents, provide the FDA with necessary information, and obtain rapid\n    product approval.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eNavigate the FDA drug approval system\u003c\/li\u003e\n\u003cli\u003ePrepare an IND\u003c\/li\u003e\n\u003cli\u003ePrepare an NDA\u003c\/li\u003e\n\u003cli\u003eNavigate the FDA review process\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\u003cli\u003eThis course is intended for Regulatory, Clinical,\n        Manufacturing, Technical, and Quality Personnel who require an in-depth\n        understanding of the drug approval system. The course will also benefit\n        management, legal, and other personnel who must be familiar with the\n        essentials of the drug approval system and the preparation and submission\n        of related documents.\u003c\/li\u003e\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\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\"\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\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eGeneral Perspective:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eHistory; law; definitions; overview of FDA;\n            establishment registration; product listing; regulatory strategy\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eIND Process:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eFDA IND Form 1571; cover letter; table of contents;\n            introduction; investigational plan; chemistry, manufacturing, and control;\n            nonclinical studies (pharmacology and toxicology); clinical studies;\n            investigator brochure; labeling; USAN procedures; compiling IND; IND\n            filing; IND review process; amendments to IND; safety reports; annual\n            reports; IND withdrawal; IND termination\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay\n Two: 8:30 a.m. – 5:00 p.m.\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eNDA Process:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eFDA NDA Form 356(h); cover letter; index; labeling;\n            summary; chemistry section (chemistry, manufacturing, and controls\n            information; samples; methods validation package); nonclinical pharmacology\n            and toxicology section; human pharmacokinetics and bioavailability\n            section; clinical data section; safety update report; statistical section;\n            case report tabulations; case report forms; patent information on any\n            patent which claims the drug; patent certification; establishment\n            description; debarment certification; field copy certification; user fee\n            cover sheet; compiling NDA; NDA amendments; NDA review process; post-approval\n            requirements\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eExploratory IND:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eClinical information; CMC information; safety program\n            designs; GLP compliance\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eClinical Trials:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003ePhase 0 studies; Phase 1 studies; Phase 2 studies; Phase\n            3 studies; Phase 4 studies\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003eRegistration\n fees include assorted breakfast items that will be available each day ½ hour\n    prior to the start of the seminar. Also included is a Networking Lunch that\n    will be served each training day.\u003c\/p\u003e\u003cp\u003eSpecial rates are available for\n    multiple attendees from the same organization. \n    Contact Melissa Dolen at 781-972-5418 to discuss your options and take\n    advantage of the savings.     \u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\"\u003eClick here for our seminar\n                    cancellation policy\u003c\/a\u003e\u003c\/span\u003e\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 15 hours (1.5 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#: 0778-0000-19-038-L01-P.\n    Released: 10\/19. \u003c\/p\u003e\u003cp\u003e \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\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/drug-approval-process-preparation-and-processing-of-inds-and-ndas.oembed","provider":"Barnett International ","version":"1.0","type":"link"}