AGENDAINDUSTRY 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 K10:20am - 10:25am Day 1 IntroductionsElias Mallis

1:40pm - 2:20pmBenefit-Risk Considerations in Drug Development Charu Mullick, MD

1:40pm - 2:20pm510(k) Program: Overview CDR Kimberly Piermatteo

2:40pm - 3:20pm510(k) Program: Case StudyCDR Kimberly Piermatteo

3:20pm - 4:00pmIntroduction 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 - 11:45amBiocompatibilityJennifer Goode

10:25am - 11:05amAnimal Study ConsiderationsJudith A. Davis, DVM, MS

2:40pm - 4:00pmReview of Chemistry, Manufacturing Controls (CMC) of an Investigational New Drug (IND) ApplicationMaria Cecilia Tami, PhDBalajee 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, 20177:15am 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) ApplicationsKevin B. Bugin, MS, RAC

11:00am - 11:45amExpanded 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 - 1:40pmRegulatory and Administrative Components of an IND ApplicationMaureen Dillon-Parker

1:00pm - 1:40pmDevice Clinical Studies/IDE ProgramSoma 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

AGENDAINDUSTRY 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 K8:30am-8:45am Admin Announcements 8:30am-8:45am Admin Announcements

8:45am-9:00am Day 2 IntroductionsJoseph Tartal

9:00am-9:40amIntroduction to the Quality System RegulationAileen Velez Cabassa

9:40am-10:20amOverview of Non-clinical Assessment in Drug DevelopmentHanan Ghantous PhD, DABT

9:40am-10:20amRisk in the Quality SystemJoseph Tartal

10:40am-11:20amGeneral Sponsor ResponsibilitiesFaranak Jamali, MD

10:40am-11:20amNonconformancesVidya Gopal

11:20am-12:00pmGeneral Clinical Investigator ResponsibilitiesFaranak Jamali, MD

11:20am-12:00pmComplaintsStanley Liu

1:15pm-1:55pmWalkthrough of an FDA InspectionNicole M. Bell, MS

1:15pm-1:55pmMedical Device ReportingAnike Freeman

1:55pm-2:35pmAdditional Sponsors’ ResponsibilitiesJudit Milstein

1:55pm-2:35pmRegulatory ActionsTonya Wilbon

2:55pm-3:55pmFDA Communication Pathways During Drug DevelopmentRachel Brown Kichline, BS

2:55pm-3:55pmFDA Medical Device InspectionsCDR Dawn M. Braswell

3:55pm - 4:30pm 1:1 Q&A Session 3:55pm - 4:30pm 1:1 Q&A Session

2:35pm - 2:55pm BREAK

4:30pm Conference Adjournment

Wednesday, May 10, 2017

10:20am - 10:40am BREAK

12:00pm - 1:15pm NETWORKING LUNCH (Purchase On Your Own)

7:15am Registration Opens High Ballroom (Lobby Level)

8:45am-9:40am1) Now You Are Ready to Submit Your Investigational New Drug (IND) Application Practical Aspects and 30-days Safety Evaluation

2) Clinical Hold Judit Milstein