SwampFox

South Carolinz Human Research Conference

For additional information, please contact Jenny Worthington at jworthington@hsblawfirm.com.

RSVP to cbennett@hsblawfirm.com.

AGENDA:
9:00 - 9:10
Welcome and Introduction
Anne S. Ellefson, Esq.
Managing Director, Haynsworth Sinkler Boyd, P.A.

9:10 - 10:00
FDA Regulatory Requirements for Clinical Investigators and Sponsor-Investigators, Including the FDA Inspection Process
Leslie K. Ball, MD
CAPT, USPHS, Director, Division of Scientific Investigations, Office of Compliance Center for Drug Evaluation and Research, US Food and Drug Administration

10:00 - 10:15
Break

10:15 - 11:00
John Acquavella, PhD
Executive Director, Global Epidemiology, Amgen, Inc.

11:10 - 11:45
HIPAA & Research
Stephen P. Williams, Esq.
Attorney, Haynsworth Sinkler Boyd, P.A.

11:45 - 1:00
Lunch with eIRB Portal Demonstration
Randy Shelley, BSEE
HSSC Project Manager for the eIRB Collaborative Portal,
Director of Research Technology, University of South Carolina

1:00 - 3:30
Breakout Sessions

Track 1: Human Clinical Research
This session is specially designed for Clinical Trial Coordinators, IRB Members, IRB Administrators, Principals and Co-Investigators.

Track 2: Patient Safety & Quality Care Research
This session is specially designed for Nurse Researchers, Nursing Students, Nursing Professors, Quality and Safety Management.

Track 3: Social, Behavioral & Epidemiological Research
This session is specially designed for University-Based Researchers, Hospital Quality Management Staff, and Research Study Designers.

Track 4: Medical Devices
This session is specially designed for Clinical Trial Coordinators, IRB Members, IRB Administrators, Principal and Coinvestigator, University Researchers, and Biomedical Engineers.