Opening Plenary

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2024 Agenda

Fri., Sept. 27 8:30 to 9:15                                                                                  Track: Opening Plenary

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

Presenter: Jessica Rowe, MA, MS, CIP, CCRP, Director, Quality and Education, Yale Cancer Center Clinical Trials Office 
Presenter: Laura Holtz, MS, PMP, CCRP, Clinical Research Associate, Yale Center for Clinical Investigation

Fri., Sept. 27 9:15 to 10:00                                   Track: Opening Plenary

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 

Fri., Sept. 27 10:30 to 11:15                                 Track: Opening Plenary

Trends in Phase I Clinical Trial Design

Dr. Garrido-Lagune 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

Fri, Sept. 27 11:15 to 12:00                                  Track: Opening Plenary

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