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Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)

Duration : 60 Minutes

This webinar is designed to help pharma companies through the various key aspects of the Chemistry Manufacturing and Controls (CMC) information expected by FDA in an IND (Investigational New Drug) Application.

Course Objectives:

The presentation will cover the key aspects of CMC package. And will explore the individual requirements across both the Drug Substance as well as the Drug Product sections of the CMC package.

Course Outline:

•  Outline of the relevance of information from the CMC perspective
•  Understanding differences between small molecules and Biologics
•  The glimpse of CFR 312.22 with the highlight of the FDA’s primary objectives in reviewing an IND
•  Overview of Pre-IND activities
•  CMC package: IND content and Format with emphasis on the Drug Substance and Drug Product

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Regulatory affairs professionals
• Senior management executives (CEO, COO, CFO, etc)
• Drug discovery and development professionals (R&D and CMC)
• Intellectual property experts
• Project Managers and Clinical trial specialists
• Regulatory Compliance Associates and Managers
• People investing in FDA-regulated product development projects

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)

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