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Regulatory Writing is as much about knowing the regulations and guidance that govern regulatory submissions as it is about the building the intelligence, knowledge, relationships, and know-how in becoming an effective partner at the table.  This course is designed to help you

·         Gain a better knowledge of the regulations and guidance documents that govern certain regulatory documents and processes in the US and EU.

·         Gain hands on experience in thinking through and writing the CSR, a key regulatory document, and

·         Understand your role, responsibilities, critical behaviors, and practical work practices that makes you a better Regulatory Writer


  • COURSE NUMBER  FPM-40628
  • CREDIT  4.00 unit(s)


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