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

This interactive 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 2: The Drug Development Process

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Components of a Global Development Plan
Development Strategy
Manufacturing Strategy (CMC Development Plan)
Estimation of Costs of Goods
Risks and Issues