Regulatory Writing Overview


Roles, Documents, and Process

The Regulatory Writing Overview package makes it as easy as 1-2-3 for you to learn and save! 



This three-part online learning activity, Regulatory Writing Overview: Roles, Documents, and Process, will help you jump-start your career in regulatory writing by providing a comprehensive understanding of the role of the regulatory writer, the major regulatory agencies overseeing drug approval, and the documents most frequently produced during the drug development process.



The package includes three learning activities:

  1.  The Role of the Regulatory Writer
  2.  Regulatory Documents for Developing Clinical Studies and Reporting Clinical  Data
  3.  Regulatory Documents for Getting a Drug to Market and Monitoring Safety 



  • Medical writers who want to break into regulatory writing
  • People who are new to medical writing and wish to explore the regulatory writing path
  • Regulatory writers looking to expand their current area of knowledge


How much?

Special package price for all three activities
$300 each for members/$400 each for non-members.  

 Each activity is approved for 1 CE.  Completed package is approved for 3 CE.


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