Associate Director For Review Management/ Director Office of regulatory Operations, CBER
US FDA
Dr. Joneckis earned a Ph.D. in Pharmacology from the University of North Carolina at Chapel Hill. He joined CBER in 1994 as a regulatory and CMC reviewer and has also served as a senior advisor for CMC and review management issues. He reviewed a variety of biologics and device applications and participated in facility inspections for a variety of therapeutic and cellular products. He currently serves as the Associate Director for Review Management and Director, Office of Regulatory Operations at CBER, where he leads on regulatory operations and a variety of review management activities. He leads the various User Fee negotiations and implementation for CBER. He is responsible for the development, implementation, and oversight of several CBER programs including, procedures and standards for review, data standards, information technology, artificial intelligence, regulatory affairs, document control, regulatory data and database, regulatory business operations and CMC policy.
Health Authority Forum: CBER - FDA’s Center for Biologics Evaluation and Research (CBER)
Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT