Regulatory Affairs: CMC



Regulatory Affairs: CMC

Rating 3.78 out of 5 (16 ratings in Udemy)


What you'll learn
  • Identify the CMC information required for submissions to support clinical studies and marketing applications
  • Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section
  • Identify CMC changes that require agency notification
  • Be an expert in the main CMC-guidances

Description

This course provides an overview of the Chemistry, Manufacturing and Controls …

Duration 0 Hours 58 Minutes
Paid

Self paced

All Levels

English (US)

58

Rating 3.78 out of 5 (16 ratings in Udemy)

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