Early Phase Regulatory Affairs and Clinical Study Design Consideration
September 25, 2018
661 University Ave. Suite 1300
Saturday, September 25, 10:30 am – 1:30 pm
Come hear PAREXEL experts present key regulatory, clinical and commercial considerations for programs that are in the early phase of development. Learn about the optimal use of the FDA’s expedited drug development and marketing application review programs and key topics for discussion at pre-IND meetings with the FDA.
Roberta Steere, Solutions Consultant Director, Early Product Development, Oncology
Bhardwaj Desai, Vice President – Technical