Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
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. 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.Learning ObjectivesOutline of the relevance of information from the CMC perspectiveUnderstanding differences between small molecules and BiologicsThe glimpse of CFR 312.22 with the highlight of the FDA’s primary objectives in reviewing an INDOverview of Pre-IND activitiesCMC package: IND content and Format with emphasis on the Drug Substance and Drug ProductWho Should AttendRegulatory affairs professionalsSenior management executives (CEO, COO, CFO, etc)Drug discovery and development professionals (R&D and CMC)Intellectual property expertsProject Managers and Clinical trial specialistsRegulatory Compliance Associates and ManagersPeople investing in FDA-regulated product development projects
Single
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. 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.
Learning Objectives
- 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
Who Should Attend
- 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