Date(s) And Time(s):
Sep 13 2010 8:30AM - Sep 15 2010 12:15PM

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

Interest Area(s):
Clinical Research, Regulatory Affairs

Overview:

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.

WHAT YOU WILL LEARN

· 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

Target Audience:
• New regulatory affairs professionals
• Clinical researchers
• Biostatisticians
• Quality professionals
• Medical writers
• Basic researchers
• Business and marketing professionals

Event Code:
10456

Contact Information:

For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183
Email Susan.Mazak@diahome.org

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