AGENDA INDUSTRY ASSISTANCE FDA SMALL BUSINESS AND Regulatory Education for Industry (REdI) Conference D R U G T R A C K D E V I C E T R A C K 10:20am - 10:25am Day 1 Introductions Elias Mallis 1:40pm - 2:20pm Benefit-Risk Considerations in Drug Development Charu Mullick, MD 1:40pm - 2:20pm 510(k) Program: Overview CDR Kimberly Piermatteo 2:40pm - 3:20pm 510(k) Program: Case Study CDR Kimberly Piermatteo 3:20pm - 4:00pm Introduction to the Premarket Approval (PMA) Program Donna Headlee, RN, BSN, CCRP 4:00pm - 4:30pm 1:1 Q&A Session 4:00pm - 4:30pm 1:1 Q&A Session 11:05am - 11:45am Biocompatibility Jennifer Goode 10:25am - 11:05am Animal Study Considerations Judith A. Davis, DVM, MS 2:40pm - 4:00pm Review of Chemistry, Manufacturing Controls (CMC) of an Investigational New Drug (IND) Application Maria Cecilia Tami, PhD Balajee Shanmugam, PhD 4:30pm - 7:00pm Networking Opportunity (Optional Self-Pay Event) The Garden at Community Smith 2:20pm - 2:40pm BREAK Tuesday, May 9, 2017 7:15am Registration Opens High Ballroom (Lobby Level) 9:00am - 10:00am PLENARY: Regulatory Research at FDA Ksenia Blinova, PhD & Alexandre J. S. Ribeiro PhD 10:00am - 10:20pm BREAK 10:20am-11:00am Introduction to Investigational New Drug (IND) Applications Kevin B. Bugin, MS, RAC 11:00am - 11:45am Expanded Access INDs, Process Overview, and What’s New Kevin B. Bugin, MS, RAC 11:45am - 1:00pm NETWORKING LUNCH (Purchase On Your Own) 1:00pm - 1:40pm Regulatory and Administrative Components of an IND Application Maureen Dillon-Parker 1:00pm - 1:40pm Device Clinical Studies/IDE Program Soma Kalb, PhD 8:15-8:30am Administrative Announcements 8:30-8:45am Welcome Brenda Stodart, PharmD 8:45am - 9:00am KEYNOTE Ingrid Zambrana, Atlanta District Director