PDA Midwest Chapter - Development and Maintenance of the CMC Section of Drug Applications

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.

Speaker Abstracts

Anatomy of the CMC and its Lifecycle Management within the eCTD

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 the presentation of the CMC, as well as its life-cycle management.

The presentation will include:

• A summary of the origin of the Common Technical Document (CTD), established as the framework for the presentation of the CMC, through its transition to the current electronic version (eCTD) associated with electronic publishing.
• An outline of the CMC anatomy (granularity, function, content, and structure) as organized within the eCTD.
• Case-study illustrating multi-disciplinary collaboration activities associated with the preparation of the CMC and its life-cycle management.

CMC Post Approval Strategies for Biologics

Pesented by 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 on regulatory requirements across the globe (EU, Japan, South American, and South East Asia) and strategies for managing your global regulatory footprint.