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戻る Agenda
Sessions 6, 7, 8, 9, and 10
Session Chair(s)
Albert S. Yehaskel, MBA
President and CEO
Refuah Global Pharmaceutical Development, Inc., United States
Session 6: The EU Investigational Medicinal Product Dossier
- Scope
- Required Information
- Structure
- Categorical Exclusions
- Contents of a Categorical Exclusion Claim
- Environmental Assessments
- Salient Features of a CTM Label
- Sample CTM Label and Carton label
- CMC Issues in Finalizing your CTM
- Begin with the End in Mind
- What is a Target Product Profile
- Design Your Ideal Label
- TOC for a Target Product Profile (TPP)
- Changes to CTMs
- References
- Purpose and Types of SPAs
- Procedure for Request and Stability Protocol
- Format and Content of an SPA
- Binding Nature of SPAs