Back to Chemistry, Manufacturing and Controls (CMC)
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.


Credits:
5.00 RAC

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

 
Want to save more?
to see if you qualify for a lower rate.
Members: save $200.00 or more
Item Details:

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...

Back to Chemistry, Manufacturing and Controls (CMC)
View More

» View the Table of Contents

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