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.

戻る Agenda

Session 8: From Clinical Trial Material to Commercial Product

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Begin with the End in Mind
What is a Target Product Profile
Design Your Ideal Label
TOC for a Target Product Profile (TPP)
Changes to CTMs

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

Session 8: From Clinical Trial Material to Commercial Product

Session Chair(s)

Priya Jambhekar

最新情報や機会を逃さないで