Objectives
Define, document and report Adverse Events.
Prepare for, navigate and respond to an FDA audit.
Demonstrate effectively how to communicate with FDA and IRB.
References
US Food & Drug Administration (FDA)
US Department of Health & Human Services
National Institute of Health (NIH)
Speaker(s): Laura Adkins, MAP, CCRP, CCRA, CRS, AdvCRS
Speaker(s) Bio
Laura’s career in the field of research has been marked by a strong focus on regulatory affairs and ensuring the safety and integrity of research data. With a master’s degree in psychology, specifically in Industrial/Organizational Psychology, Laura began her career at the University of Arkansas for Medical Sciences (UAMS), where she spent 14 years as a data and regulatory coordinator. Her work involved monitoring regulatory compliance, data coordination, and other important research-related activities.
Her experience led her to transition into a role focused on monitoring, and she is currently serving as the Director of the Office of Research Regulatory Affairs (ORRA) at UAMS. In this role, she oversees regulatory affairs and acts on behalf of UAMS as a sponsor for FDA-regulated research involving Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). This position requires her to stay current with the constantly evolving regulations and requirements in the field of research.
Throughout her over 20-year career, Laura has emphasized the importance of continuous learning due to the dynamic nature of research regulations. She is dedicated to supporting researchers and their teams, providing guidance and education to help them navigate the complexities of research requirements. Her personal goal is to contribute to the local community by advancing research, offering support for all study-related activities, and ensuring the safety of research subjects and the integrity of data.
DCOC Contact Information
Catrice Banks-Johnson
Email: crbanksjohnson@uams.edu
DeAnn Hubberd
Email: DEHubberd@uams.edu
