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DIA Global Center

11 sep 2017 8:15 a.m. - 12 sep 2017 3:30 p.m.

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

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

Volver a 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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