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.
Please note: This class is only open to the first five students who enroll.
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.
Course Number: FPM-40628
Credit: 4.00 unit(s)
Related Certificate Programs: Medical Writing