Regulatory Science Boot Camp:
Patient-Centered Drug Development &
Real World Evidence/Data
Friday, March 15th, 2019
9:00am - 4:00pm
You will receive a certificate of completion at the end of the boot camp. Hours may be eligible for SoCRA and/or ACRP credit.
RSCI 521 credit available upon approval. Contact Toni Rodriguez | [email protected] .

Agenda
8:15 am
Check-In & Breakfast
9:00 am
9:40 am
History, Terms and Definitions | Nancy Pire-Smerkanich, DRSc, MS
10:40 am
 Break
10:40 am
Patient-Centered Drug Development | Mladen Bozic, MS
Shire | Vice President and Head, Global Regulatory Policy
11:45 pm
Lunch (provided) & Networking
1:00 pm
Rare Diseases | Mladen Bozic, MS
1:45 pm
Real World Evidence and Real World Data | Klaus A. Romero Cepeda, MD, MS
The Critical Path Institute | Director, Clinical Pharmacology and Quantitative Medicine
USC , SC-CTSI , School of Pharmacy | Adjunct Professor
2:45 pm
Break
3:05 pm
3:45 pm
4:00 pm
Adjourn
SC CTSI is part of the Clinical and Translational Science Awards (CTSA) , a national network funded through the
National Center for Advancing Translational Sciences (NCATS) at the NIH (Grant Number UL1TR001855). Under the mandate of “Translating Science into Solutions for Better Health,” SC CTSI provides a wide range of services, funding, and education for researchers and promotes online collaboration tools such as USC Health Sciences Profiles
Contact Amelia Spinrad for more information | [email protected] | (323) 442-1598