Regulatory Science Boot Camp/Symposium:
Legal Aspects of Clinical Trials
Friday, November 1st, 2019
9:00am - 4:00pm
You will receive a certificate of completion at the end of the boot camp/symposium. Hours may be eligible for SoCRA and/or ACRP credit.
RSCI 521 credit available upon approval. Contact Toni Rodriguez | tonirodr@usc.edu .

Agenda
8:15 am
Check-In & Breakfast
9:00 am
9:45 am
Investigator Responsibilities: Industry Sponsored Studies I Nancy Pire-Smerkanich, DRSc
USC, SC-CTSI, School of Pharmacy  I Assistant Professor, Dept. of Reg. & Quality Sciences
10:15 am
10:30 am
 Break
Investigator Responsibilities: Investigator Initiated Trials I Nancy Pire-Smerkanich, DRSc
USC, SC-CTSI, School of Pharmacy  I Assistant Professor, Dept. of Reg. & Quality Sciences
11:00 am
Clinical Trials Contracts | Melissa Archer, J.D.
USC Clinical Trials Office, Keck School of Medicine | Director
11:45 pm
Lunch (provided) & Networking
1:00 pm
Legal Considerations of Compassionate Use  I Kellie Ann Moore, Esq. MS
USC, School of Pharmacy  I Adjunct Faculty  
1:45 pm


2:30 pm
Liability and Indemnification  I Kellie Ann Moore, Esq. MS
USC, School of Pharmacy  I Adjunct Faculty
Break
2:45 pm
Privacy and HIPAA | Terence Hogan
RGP Healthcare | Partner, Regulatory, Compliance, GXP and Privacy
3:30 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 A purva Uniyal for more information | uniyal@usc.edu | (323) 442-6670