ATMPs in Focus: Essential CMC Strategies for Every Phase

Available on-demand

January 25, 2024 - 11:00AM ET

During this webinar, we will explore the possibilities offered by a phase-specific regulatory strategy for overcoming challenges associated with the CMC (Chemistry, Manufacturing, and Controls) approach for ATMPs. Employing a phase-specific approach is crucial for optimizing time and cost savings in regulatory compliance while effectively managing expectations during each stage of clinical development

Webinar Learning Objectives:

• Outline details for taking a phase appropriate approach

• Discuss specification and stability strategies for early phase development

• Discuss ways Sponsors can ensure their phase-appropriate approach will be accepted

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