This course combines the two three-day courses into one extended five-day offering.It describes the regulatory background of the IND and NDA and provides an overview of the requirements and recommendations for preparing and managing these applications.Please note that this August offering is a 5 day version of Regulatory Affairs: Part I: The IND Phase and Part II: The CTD/NDA Phase.
Organized by:
Drug Information Association
Invited Speakers:
1) Roger W CroswellPresidentRegulatory Consulting Services, LLC
United States.
2) Michael R. Hamrell, PhD, RAC President MORIAH ConsultantsUnited States.
3) Drusilla L. Scott, PhD, RACVP, Regulatory AffairsCempra PharmaceuticalsUnited States.