DIA
Drug Information Association Logo

#22: Utilizing Chemistry, Manufacturing, and Controls in Drug Development

Tutorial name:
#22: Utilizing Chemistry, Manufacturing, and Controls in Drug Development

Day & Time:
June 24, 8:30AM - 12:00PM

Room Number:
120BC

Description:
Maximize your learning while attending the DIA 2012 Annual Meeting! Receive $100 off of your DIA 2012 meeting registration by registering for two half day tutorials (#20-34) or one full day tutorial (#40-48). Purchases must be made at the same time in order to receive the discount.

This tutorial will provide you with the tools to write or assemble CM&C sections of regulatory submissions and other regulatory documents, and adequately prepare you for CM&C meetings with the FDA. Participants will discuss all the CM&C components of INDs and NDAs/CTDs, provide appropriate tools to write or assemble CM&C sections of regulatory submissions and documents, prepare for CM&C meetings with FDA, and navigate through the myriad guidelines and guidance documents.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:

• Recognize FDA’s regulatory expectations and the regulatory framework

•Outline the CM&C sections of INDs/NDAs/CTDs/DMFs

• Assemble the CM&C sections of INDs and NDAs/CTDs

• Describe regulatory documents affected by CM&C



Target Audience:
This tutorial is designed for regulatory affairs professionals, quality assurance and compliance personnel, and manufacturing personnel.

© 2015 DIA