This course provides a comprehensive approach to the preparation and submission of documents to the FDA for approval of drug products. Participants receive a foundation of knowledge about the drug approval process, submission preparation, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and assembly of INDs, NDAs, and post-approval documents. Information on maintaining on-going relationships with the FDA is also discussed. The course enables regulatory affairs professionals to prepare concise documents, provide the FDA with necessary information, and obtain rapid product approval.
This course is intended for Regulatory, Clinical, Manufacturing, Technical, and Quality Personnel who require an in-depth understanding of the drug approval system. The course will also benefit management, legal, and other personnel who must be familiar with the essentials of the drug approval system and the preparation and submission of related documents.
The course will be led by one of the following instructors:
Albert A. Ghignone, M.S., R.A.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- General Perspective: History; law; definitions; overview of FDA; establishment registration; product listing; regulatory strategy
- IND Process: FDA IND Form 1571; cover letter; table of contents; introduction; investigational plan; chemistry, manufacturing, and control; nonclinical studies (pharmacology and toxicology); clinical studies; investigator brochure; labeling; USAN procedures; compiling IND; IND filing; IND review process; amendments to IND; safety reports; annual reports; IND withdrawal; IND termination
Day 2: 8:30 a.m. – 5:00 p.m.
- NDA Process: FDA NDA Form 356(h); cover letter; index; labeling; summary; chemistry section (chemistry, manufacturing and controls information, samples, methods validation package); nonclinical pharmacology and toxicology section; human pharmacokinetics and bioavailability section; clinical data section; safety update report; statistical section; case report tabulations; case report forms; patent information on any patent which claims the drug; patent certification; establishment description; debarment certification; field copy certification; user fee cover sheet; compiling NDA; NDA amendments; NDA review process; post-approval requirements
- Exploratory IND: Clinical information; CMC information; safety program designs; GLP compliance
- Clinical Trials: Phase 0 studies; Phase 1 studies; Phase 2 studies; Phase 3 studies; Phase 4 studies
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-10-003-L01-P. Released: 10/10.
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For more information, contact Naila Ganatra at (215) 413-2471.