Introduction to Non-Clinical Regulatory Writing

8:55 AM - 9:20 AM

This presentation will provide an overview of nonclinical regulatory writing, particularly as it relates to the development of regulatory documents in preparation of FIH IND submissions from planning to approval. The relationship of nonclinical technical reports to regulatory documents, as well as some approaches to improve the efficiency of nonclinical document development, will be discussed.  The role of nonclinical writers in drug development and some skills needed to successfully support teams and regulatory submissions will also be discussed.