Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

This interactive virtual training course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

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Session 4: CMC Requirements for an Investigational New Drug

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Part A: Drug Substance

Part A of the IND will discuss in detail how to design the Drug Substance portion of an IND with real examples

Part B: Drug Product

Part B of the IND will discuss in detail how to design the Drug Product portion of an IND with real examples

Part C: Placebo

Part C of the IND will discuss in detail how to design the Placebo portion of an IND in the event placebos are used in clinical trials