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Sessions 25 and 26
Session Chair(s)
Albert S. Yehaskel, MBA
President and CEO
Refuah Global Pharmaceutical Development, Inc., United States
Session 25: Beyond Approval – Post Approval Changes
- This section will drill down into the realm of post approval changes such as PAS's, CBE's, and ARs
- SUPAC documents will be discussed which are integral in the post approval world
- Components and Composition
- Manufacturing Sites and Process
- Specifications
- Container/Closure System