PDA Chapter Dinner - 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.

  1. Anatomy of the CMC and its Life Cycle 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 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 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.
  1. CMC Post Approval Strategies for Biologics

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.

DATE: November 14, 2019 - 5:00 pm – 8:30pm

5:00pm         Registration, cocktails, and networking

6:00pm         Dinner

7:00pm         Presentation 1

Speaker 1:    Daniel J. Hoch Ph.D. Vice President, Protocol Link Inc

Title:             Anatomy of the CMC and its Life Cycle Management within the eCTD

Length:         30 Minutes

Abstract:       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.

7:30pm:        Question and Answer Session for Speaker 1 and Coffee Break

7:45pm         Presentation 2

Speaker 2:    Kathy Lee, Senior Research Advisor CMC, Eli Lilly and Company

Title:             CMC Post Approval Strategies for Biologics

Length:         30 Minutes

Abstract:       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.

8:15pm:        Question and Answer Session for Speaker 2

8:30pm         Closing remarks / upcoming events

 

Event Properties

Event Date 11-14-2019 5:00 pm
Event End Date 11-14-2019 8:00 pm
Capacity Unlimited
Individual Price $65.00
Location
Crowne Plaza, Northbrook IL
2875 Milwaukee Avenue, Northbrook, IL 60062, USA
Crowne Plaza, Northbrook IL
$65.00
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