Chemistry, Manufacturing and Controls

Information regarding chemistry, manufacturing and controls (CMC) for drugs is an important and detailed section in a dossier to support clinical studies and marketing applications. This information must be updated throughout a drug’s 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—including Drug Master Files (DMFs)—and information on CMC specific guidances.

The CMC section is synonymous with the quality section in some formats, such as the Common Technical Document (CTD). For ease of review, this course will describe it generically as the CMC section.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

At A Glance

  • Target Audience: This course is designed for regulatory, quality assurance and manufacturing personnel; individuals who are new to drug companies; and professionals assuming management of a CMC area
  • Learning Level: Basic
  • Total Length of Course: 5–10 Hours
  • RAC Credits: 5
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $535; List $735
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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 Drug Master Files (DMFs)

Lesson Titles

  • Lesson 1: General CMC Information
  • Lesson 2: Clinical Trials
  • Lesson 3: Marketing Applications
  • Lesson 4: Postapproval CMC
  • Lesson 5: CMC-Specific Guidance

Registration Options

This course is available for purchase as follows: