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Virtual Training Course (US Eastern Time)

13 jul 2020 9:00 a.m. - 16 jul 2020 2:00 p.m.

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

Session 8: Special Protocol Assessment

Session Chair(s)

Priya  Jambhekar

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

  • 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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