Associate Director For Review Management, CBER
US FDA
Chris Joneckis, Ph.D., servesas the Associate Director for Review Management for the Center For Biologics Evaluation and Research (CBER) at FDA. In this capacity, he Is the Center’s authoritative expert on review management, directing the review management staff and providing leadership for review program activities executed throughout the offices of CBER. He has a principal role in user fee negotiations. He is responsible for the development, implementation and oversight of several CBER programs including; policies, procedures and standards for review, data standards, information technology, regulatory affairs, document control, regulatory database and regulatory business operations and Chemistry Manufacturing and Controls policy.
Disclosure information not submitted.
Tuesday, September 13, 2022
9:45 AM – 11:00 AM MST