Introduction
Eunjoo Pacifici, PharmD, PhD
USC, SC-CTSI, School of Pharmacy I Chair & Associate Professor, Dept. of Reg. & Quality Sciences l Associate Director, DK Kim lnternational Center for Regulatory Science
Clinical Investigation: Value and Key Aspects of the IMDRF Guidance Document
Maria E. Donawa, MD
President, Donawa Lifescience Consulting
Good Clinical Practices and ISO 14155
Danielle Giroud, RN, MBA
Founder, CEO, MD-Clinicals
From Clinical Data to Clinical Evidence
Cheryl Hergert, MPH
Principal Clinical Quality Specialist, Medtronic
Developing Clinical Evaluations
Evangeline Loh, PhD, RAC (US, EU)
Global Regulatory Manager, Emergo by UL
Wrap-Up
Eunjoo Pacifici, PharmD, PhD
USC, SC-CTSI, School of Pharmacy I Chair & Associate Professor, Dept. of Reg. & Quality Sciences l Associate Director, DK Kim lnternational Center for Regulatory Science