A special session: Meet the regulator
Meet the regulator in a special session, interact with FDA specialist
and receive insightful answers regarding FDA initiatives.
Quality, Quality by Design, Biotechnology Products and US FDA Initiatives
Dr. Steven Kozlowski
CDER, FDA, Silver Spring, MD USA 
followed by
Meet The Regulator and The Pharmacepoiea
Questions and Answers
By Steven Kozlowski, CDER, FDA
and Karen A. Russo, Ph.D.
Vice President, Small Molecules
Documentary Standards Division, United States Pharmacopeia