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Regulatory Strategy in Drug Development

Categories: Drug-development
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About Course

Learn how to design a regulatory strategy for successful global submissions (FDA, EMA) throughout the drug development lifecycle.

 

What Will You Learn?

  • Drug discovery and preclinical stages
  • Clinical trial phases (I-IV)
  • Regulatory submission (NDA/ANDA/IND)
  • Post-marketing activities and pharmacovigilance

Course Content

Overview of Drug Development

  • Overview of Drug Development

Target Identification & Screening

Preclinical Testing

IND Application Process

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