Regulatory Affairs Part I: The IND Phase Course

Date(s) And Time(s):
Jun 17 2011 10:30AM - Jun 19 2011 11:45AM

McCormick Place
2301 South Lake Shore Drive
Chicago, IL 60616-1497

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

Target Audience:

· New regulatory affairs professionals
· Clinical researchers
· Biostatisticians
· Quality professionals
· Medical writers
· Basic researchers
· Business and marketing professionals

Event Code:

Contact Information:
For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183