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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 2: The Drug Development Process

Session Chair(s)

Priya  Jambhekar

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

  • Target Product Profile
  • Components of a Global Development Plan
  • Development Strategy
  • Manufacturing Strategy (CMC Development Plan)
  • Changes to the CMT
  • Estimation of Cost of Goods
  • Risks and Issues Exercise

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