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)
Related Certificate Programs: Medical Writing
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