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Navigating CMC Requirements during drug development and post-approval

pharmafile | April 30, 2018 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing dia 

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.

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

Register here or, for more information, please contact EMEA@DIAglobal.org

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