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DIA Global Center

Sep 11, 2017 8:15 AM - Sep 12, 2017 3:30 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

Back to Agenda

Sessions 6, 7, 8, 9, and 10

Session Chair(s)

Albert S. Yehaskel, MBA

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

Session 7: Environmental Impact (IND and NDA)

Categorical Exclusions
Contents of a Categorical Exclusion Claim
Environmental Assessments

Session 8: Designing the Clinical Trial Material (CTM) Label

Salient Features of a CTM Label
Sample CTM Label and Carton label
CMC Issues in Finalizing your CTM

Session 9: From Clinical Trial Material to Commercial Product

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

Session 10: Special Protocol Assessment

Purpose and Types of SPAs
Procedure for Request and Stability Protocol
Format and Content of an SPA
Binding Nature of SPAs

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