Capstone: Regulatory Writing

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

*To be eligible to take this course you must have completed all of the other courses in the Medical Writing program with a B-/80% or higher.