Course Learning Outcome

Upon completion of the course, the student will be able to

  • Explain the process of drug discovery and development and generic product development in pharmaceutical sector.
  • Compare between regulatory approval process and registration procedures for drug products as per requirement of different countries like US, EU, Japan, Australia, UK and Canada
  • Prepare necessary documents for regulatory approval process for Medical Devices, In vitro Diagnostics, biologics, biosimilars etc.
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