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5.00 RAC

Chemistry, Manufacturing and Controls (CMC)

This course provides an overview of the CMC section of dossiers, including the CMC information necessary to support a marketing application.

5.00 RAC

  • List Price: $735.00
  • Member Price: $535.00

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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...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design