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 1: Types of Submissions Affected by CMC

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

FDA Briefing Package
Investigational New Drug Application (IND)
Investigational Medicinal Product Dossier (IMPD)
New Drug Application (NDA/CTD) and Biologics License Application (BLA)
Common Technical Document (CTD)
Drug Master Files (DMF)
Abbreviated New Drug Application (ANDA)
Amendments to an IND
Supplements to an Approved NDA/ANDA
IND/NDA Annual Reports

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

Session 1: Types of Submissions Affected by CMC

Session Chair(s)

Priya Jambhekar

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