Information regarding Chemistry, Manufacturing and Controls (CMC) for drugs is an important and detailed section in dossiers that supports clinical studies and marketing applications. This information must be updated during a drug’s entire lifecycle. The required content and format of the CMC section of various application types are described in guidance documents from both the International Conference on Harmonization (ICH) and individual regions.
This course provides an overview of the CMC section of dossiers. It discusses the CMC information necessary to support original investigational applications; identifies CMC changes that would require investigational application amendments; and provides the CMC information necessary to support a marketing application, information on required postapproval submissions, and information on CMC specific guidances—including Drug Master Files (DMFs).
Learning Objectives
Upon completion of this course, participants should be able to:
- Identify the CMC information included in submissions to support clinical studies and marketing applications
- Discuss the role of ICH and individual regional guidances that should be referenced in order to prepare a CMC section
- Identify CMC changes that will require agency notification
- Explain different types of postapproval submissions
- Describe the use of DMFs
Target Audience
This course is designed for regulatory, quality assurance and manufacturing personnel; individuals who are new to drug companies; and executive management.