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Virtual Training Course (US Eastern Time)

2020年7月13日 (月) 午前 9:00 - 2020年7月16日 (木) 午後 2:00

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.

Session 4: CMC Requirements for an Investigational New Drug

Session Chair(s)

Priya  Jambhekar

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

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