Drug Development and FDA Regulations: A Regulatory Overview

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Sample Course Material!

This course provides a comprehensive overview of the drug development process, including GLP, GCP and GMP processes. It is specially geared toward new industry professionals who need to develop an understanding of the drug development process.

Learning Objectives

Discuss the FDA’s role in drug development
Explain the logic of the drug development process
List content requirements of IND/NDA
Cite the basics of clinical trial structure and design
Explain the post-approval responsibilities of sponsors
Describe the fundamentals of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP)
Examine the structure and process of the FDA review of an IND/NDA

Clinical Research Associates and Auditors who want a greater understanding of the drug development process and their role in it
Regulatory Affairs Professionals who may be new to their positions or want a more complete understanding of how the FDA regulates new drug development
Clinical Research Coordinators who want to learn about the drug development process
GMP Specialists and those involved in device development that find themselves moving into the drug development area
Project Managers who need an overview of all areas of drug development and the interrelationship and interdependence of other departments

The course will be led by one of the following instructors:

Gary B. Freeman, M.S., C.C.R.A.
Albert A. Ghignone, M.S., R.A.C.

Click here for complete trainer biographies

Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

Introduction
History
Law
Logic of Drug Development
The FDA’s Role in Drug Development
Non-Clinical Drug Testing – Good Laboratory Practices
The Gateway to Clinical Testing: FDA advisory committees FDA advisory committees
The IND: General content of the IND; commercial INDs; investigator INDs; treatment INDs; emergency-use INDs
The FDA’s IND Review: The structure of FDA review; the 30-day review process

Day 2: 8:30 a.m. – 5:00 p.m.

The Clinical Testing of New Drugs: The structure of clinical trials (Phase I, II, and III); clinical trial design – five types of controls
Good Clinical Practices: The three elements of GCP (sponsor responsibility, investigator responsibility, IRB responsibility)
The NDA and the NDA Review: NDA content; sponsor responsibility during NDA review; the FDA and its review; FDA advisory committees FDA advisory committees
Post-Approval Sponsor Responsibilities: NDA field alert; annual reports; adverse drug reports; advertising/promotional labeling; GMP review process

What is a New Drug? Group Activity
Patient Enrollment through Various Phases of Development

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.

Click here for our seminar cancellation policy

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# 0778-0000-09-019-L01-P. Released: 10/09.