| |
|
|
| |
|
|
| |
HUM-MOLGEN
-> Events
-> Courses and Workshops |
|
|
| |
| |
| |
April 10, 2011 |
|
|
| |
|
|
| |
|
|
|
Drug Information Association, Inc, Horsham, PA USA
Sep 21 2011 8:30AM - Sep 23 2011 12:15PM
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)
Event Code:
11434
|
|
|
|
|
|
|
|
Organized by:
|
|
DIA |
|
|
Invited Speakers:
|
|
See website for speaker information
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
Call contact
|
|
|
|
|
|
|
|
Registration:
|
|
For detailed program information including faculty and topics, please contact: Susan Mazak Tel. +1-215-442-6183
|
|
|
E-mail:
|
|
susan.mazak@diahome.org
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp,
Frank S.
Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved.
Liability, Copyright and Imprint. |
|