Universidad Miguel Hernández Elche

Instituto de Investigación de Drogodependencias

Drogas. Investigación, formación y aplicación de programas y recursos

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DÍA A DÍA: Descripción de un evento

Drug Approval Process: Preparation and Processing of INDs and NDAs

Entidad que organiza
healthtech.com
Tipo de Evento
Jornadas
Lugar de realización
Philadelphia, PA
Fecha inicio
27/09/2010
Fecha fin
28/10/2009
Decripción del evento
Course Description

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.

Learning Objectives

* Navigate the FDA drug approval system

* Prepare an IND

* Prepare an NDA

* Navigate the FDA review process

Who Should Attend

* 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.

Course Outline

Day 1: 8:30 a.m. - 5:30 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. -5:30 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

There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.
Información de contacto:
Accreditation Information

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# 778-000-07-009-L01-P. Released 7/07.


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eandrews@healthtech.com
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