| |
|
|
| |
|
|
| |
HUM-MOLGEN
-> Events
-> Courses and Workshops |
|
|
| |
| |
| |
August 30, 2011 |
|
|
| |
|
|
| |
|
|
|
Center for Professional Innovation & Education (CfPIE), King of Prussia, PA
Dec. 8 & 9, 2011
This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND in CTD format. Participants will gain a thorough understanding of the requirements for each CMC section of the Common Technical Document (CTD), i.e., the format to be used for NDAs. Additionally, the course will suggest ways to streamline the preparation of CMC documents, present techniques for making the CMC submission easy to review, and discuss how to address issues during CMC meetings with the FDA.
|
|
|
|
|
|
|
|
Organized by:
|
|
Center for Professional Innovation & Education |
|
|
Invited Speakers:
|
|
Contact info@cfpie.com for a list of course instructors
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
http://www.cfpie.com/showitem.aspx?productid=061&source=hummolgen
|
|
|
E-mail:
|
|
info@cfpie.com
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
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. |
|