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Overview

CMC systems and processes play a pivotal role in the development, licensure, manufacture, and ongoing marketing of biopharmaceutical and device products that are consistently effective, safe, and high quality for patients.

DIA's CMC Workshop will provide a thorough understanding of the regulatory, technical, and quality requirements and strategies needed to support problem-solving as well as continuous improvements and innovation in biopharmaceutical manufacturing. Opportunities for interactive sharing of information and approaches will be an important part of the program.

This program has been developed in collaboration with the DIA CMC Working Group and Regulatory Affairs Community.


CMC Resource Guide

What's going on in CMC? Check out our Resource Guide for the latest news in the field including reoccurring challenges and possible solutions, as well as informative articles and exclusive podcast interviews. Also gain more insight into the CMC Workshop and what hot topics will be discussed.

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On-Demand Content Preview Webinar

Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes.
Listen in on a recording from the DIA 2018 Global Annual Meeting, with a Q&A at the end with experts Peter Lassoff, PharmD, FTOPRA, and Mark Wiggins, MS.
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Who should attend?

Professionals involved in:

  • CMC Regulatory Affairs
  • CMC Writing
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • API Development and Manufacturing
  • Formulation Development and Manufacturing
  • Analytical Development
  • CMC Lifecycle Management
  • CMC Project Management

Learning objectives

At the conclusion of this workshop, participants should be able to:
  • Discuss the current CMC topics for chemical and biological products in a globalized environment
  • Explain challenges and opportunities for CMC and GMP in accelerated drug development
  • Discuss the impact of emerging technologies in drug development
  • Describe recent ICHQ2 and ICHQ14 updates
  • Discuss concepts of the patient centric Quality Overall Summary (QOS) as advanced by FDA
  • Discuss challenges in the development and manufacture of complex drug delivery devices
  • Outline the current general process for complex generics approval
  • Describe CMC regulatory updates in international markets
  • Explain the concepts and elements of process monitoring for CMC

Program Committee

  • LeeAnn L Chambers, MS
    LeeAnn L Chambers, MS Principal Research Scientist, Global Regulatory Affairs, CMC - Devices
    Eli Lilly and Company, United States
  • Andrew  Chang, PhD
    Andrew Chang, PhD Vice President, Quality and Regulatory Compliance, QI&I, Corporate Quality
    Novo Nordisk A/S, United States
  • Cheryl  Emery
    Cheryl Emery Associate VP, GRACS and Global Head CMC Pre-Approval Pharmaceuticals
    Merck Research Laboratories, United States
  • M. Scott  Furness, PhD
    M. Scott Furness, PhD Deputy Director, ONDP, OPQ, CDER
    FDA, United States
  • Annie W Sturgess, PhD
    Annie W Sturgess, PhD Vice President, Global Regulatory Sciences, CMC
    Bristol-Myers Squibb Company, United States
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