The PDA Midwest Chapter is pleased to present two speakers for our November 2019 event to focus on topics related to the development and maintenance of the chemistry, manufacturing and controls (CMC) section of a drug application.
Presented by Daniel J. Hoch Ph.D. Vice President, Protocol Link Inc.
The presentation will focus on the composition and management of the Chemistry, Manufacturing and Controls (CMC) Section applicable to drug product submissions to the US-FDA. It will outline the structural elements of the Common Technical Document (CTD) as the framework for presentation of the CMC, as well as its life-cycle management.
The presentation will include:
Kathy Lee, Senior Research Advisor CMC, Eli Lilly and Company
The CMC post approval global regulatory landscape is an exciting and challenging space for biologics. This talk will focus regulatory requirements across the globe (EU, Japan, South American and South East Asia) and strategies for managing your global regulatory footprint.