SOCRA 2024 Annual Conference Program Book - Flipbook - Page 32
FRIDAY, SEPTEMBER 27, 2024
OPENING PLENARY
Location: Paradise Event Center North
I
Moderator: Laura Holtz, MS, PMP, CCRP
8:30 to 9:15
Welcome and Introduction
Ms. Rowe and Ms. Holtz will describe issues related to the practice of clinical research in the current regulatory
environment and how SOCRA works to promote education and training within the clinical research community. 001
Presenters: Jessica Rowe, MA, MS, CIP, CCRP, Director, Quality and Education, Yale Cancer Center Clinical Trials
Office
Laura Holtz, MS, PMP, CCRP, Senior Quality Specialist, Yale University, Yale Cancer Center Clinical Trials Office
9:15 to 10:00
FDA Initiatives
Dr. Cochran will share FDA organizational structure and current initiatives. 002
Presenter: Chrissy Cochran, PhD, Program Director, Office of Bioresearch Monitoring, U.S. Food and Drug
Administration
10:30 to 11:15
Trends in Phase I Clinical Trial Design
Dr. Garrido-Laguna will provide a Phase I clinical trial design overview. The Project Optimus FDA initiative will be
explained and future directions for Phase I research will be addressed. 003
Presenter: Ignacio Garrido-Laguna, MD, PhD, Phase I Program Director, Huntsman Cancer Institute
11:15 to 12:00
Research Protections and HHS/OHRP Initiatives
Ms. Kaneshiro will discuss the importance and the impact of all the regulations and guidance associated with
human research protections as applied to clinical research. We will consider the OHRP mission, and its structure
and how OHRP provides leadership in the protection involved in research conducted or supported by the U.S.
Department of Health and Human Services. 004
Presenter: Julie Kaneshiro, MA, Acting Director, OHRP, HHS
- 32 7
9
