Friday, August 12, 2011

Regulatory Affairs: Part 1: The IND Phase (training course)

If you're interested in pursuing a career in regulatory affairs, don't miss this DIA training course titled, Regulatory Affairs: Part 1: The IND Phase

Dates: Sep 21 2011 8:30AM - Sep 23 2011 12:15PM

Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Interest Area(s): Clinical Research,Professional Education, Training & Development,Regulatory Affairs

All You Need to know about IND Submissions in Only 3 Days

Learn how to apply regulatory concepts to ensure compliant IND submissions to FDA. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

· Overview of the drug development process
· The IND process
· Quality assurance in drug development (GXPs)
· FDA’s actions on the original IND and amendments
· Activities and submissions after the original IND
· How to interact with FDA
· Procedures for reporting adverse events (AEs)

Learning Objectives:
At the conclusion of this course, participants should be able to:
· Apply the role of regulatory affairs and the impact on the drug development process
· Discuss the role of FDA and composition of FDA’s review teams
· Effectively plan and submit an IND
· Report adverse events accurately and correctly to the FDA
· Apply common meeting etiquette in dealing with the FDA during the IND/NDA phases

More information here.

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