12:30 – 1:30 | Lunch with the Regulators
Moderators: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA and Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.
Grab your boxed lunch and bring questions for U.S. FDA investigators, reviewers, and compliance officers to this Q&A session that will allow for direct input and will provide you with insights regarding inspection trends and center initiatives.
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA
Laura S. Huffman, MS, Senior Policy Advisor, CVM, U.S. FDA
Jeffrey D. Meng, MSE, Program Division Director, OPQO, ORA, U.S. FDA (INVITED)
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA
Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA
Wei Wang, PhD, Microbiologist, CBER, U.S. FDA