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Navigating CMC Requirements During Drug Development and Post-Approval

This training will offer you the overview of the existing regulatory aspects of the CMC, and will also give you a proper understanding on how to face the challenges during the drug development and its post-approval.


Overview

The competitive environment of pharmaceutical companies that are developing new drugs is pushing the experts to find new and creative ways to increase the acceleration process of the drug development. Focusing on clinical trial part, sometime, the CMC section is often not given the same attention as needed. The occurred CMC challenges can be faced with proper training and understanding of the different approaches from global to regional guidance.

This training will not only offer you the overview of the existing regulatory aspects of the CMC, but it will also give you a proper understanding on how to face the challenges during the drug development and its post-approval.

 

What you will learn

  • Overview of Global development process and guidance
  • Drug substance requirements from manufacturing to preformulation studies and analytical validation
  • Drug product specification and stability
  • Lifecycle management

Who should attend?

  • Quality assurance and compliance experts
  • CMC and manufacturing personnel
  • Regulatory affairs professionals

 

 

Learning objectives

At the conclusion of this course, participants will be able to:

  • Understand the guidelines proposed by FDA/EMA/WHO and ICH
  • Learn the CTD structure and the alternative submission type for CMC documentation
  • Identify the differences between IND/IMPD requirements in EU and US
  • Assess the drug manufacturing requirements
  • Be prepared for inspections

Learning objectives will be achieved using a mix of trainer presentations, trainer-led plenary discussions and case studies.


Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

  • Focus
  • Flexibility
  • Convenience
  • Cost Effectiveness

For more information please contact EMEA@DIAglobal.org

Contact us



Registration Questions

Send Email
+41 61 225 51 51


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+41 61 225 51 55