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Tuesday, June 18 • 4:30pm - 5:30pm
#285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-617-L04-P; CME 1.00; RN 1.00

This session will describe the evolution of remote regulatory assessments (RRA’s), FDA’s authority to conduct an RRA in lieu of an inspection, the process for conducting an RRA, and recent RRAs conducted as part of the FY23 BIMO program

Learning Objectives

Describe what a remote regulatory assessments is and FDA’s authority to conduct a remote regulatory assessment; Describe the steps taken by the agency and site before, during, and after a remote regulatory assessment is conducted; Discuss FY23 metrics including recently conducted remote regulatory assessments.

Chair

Jan Hewett, BSN, JD

Speaker

FDA Update
Kavita C. Dada, PharmD

Industry Perspective on Remote Assessments
James Riddle

Health Canada Update
Jennifer Evans


Speakers
KD

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States
JE

Jennifer Evans

Compliance Specialist, Health Canada, Canada
Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a regulatory... Read More →
avatar for Jan Hewett

Jan Hewett

Regulatory Counsel for Policy, OSI, CDER, FDA, United States
Jan Hewett joined the U.S. Food and Drug Administration's Center for Drug Evaluation and Research -Office of Compliance- Office of Scientific Investigations office as Regulatory Counsel (Policy) in February 2015. Prior to joining OSI, Jan served as the Director of the Yale University... Read More →
avatar for James Riddle

James Riddle

Senior Vice President, Global Review Operations, Advarra, United States
JJames Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session