Welcome
• Eunjoo Pacifici, PharmD, PhD — USC Mann, SC-CTSI; Chair & Associate Professor; Associate Director, DK Kim International Center for Regulatory Science
Investigational New Drug (IND)
• Nancy Pire-Smerkanich, DRSc — USC Mann, SC-CTSI; Assistant Professor; Associate Director, Regulatory Knowledge and Support
Combination and Innovative Products – Drugs/Biologics and Devices
• James Wabby, BSc., MHMS — Executive Director of Regulatory Affairs, AbbVie
• Nancy Pire-Smerkanich, DRSc, MS — USC Mann, SC-CTSI; Assistant Professor; Associate Director, Regulatory Knowledge and Support
Safety Reporting – Lecture and Workshop
• Nancy Pire-Smerkanich, DRSc, MS — USC Mann, SC-CTSI; Assistant Professor; Associate Director, Regulatory Knowledge and Support
Pediatric Clinical Trials and Study Plans
• Tony Succar, PhD, MScMed (OphthSc) — USC Mann, SC-CTSI; Assistant Professor
Benefit/Risk Assessment – Lecture and Activity
• Nancy Pire-Smerkanich, DRSc, MS — USC Mann, SC-CTSI; Assistant Professor; Associate Director, Regulatory Knowledge and Support
Wrap Up
• Eunjoo Pacifici, PharmD, PhD — USC Mann, SC-CTSI; Chair & Associate Professor; Associate Director, DK Kim International Center for Regulatory Science
