Regulatory Affairs Part I: The IND Phase

Date(s) And Time(s):
Mar 15 2010 8:30AM - Mar 17 2010 3:30PM

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

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)

Contact Information:

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