Download Breakout Session Overviews | Download Schedule of Breakout Sessions | View Conference Schedule
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
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
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
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