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Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment
Session Chair(s)
Patrick Ricucci, PMP
Associate Director of Regulatory Affairs (Acting), ONDP, OPQ, CDER
FDA, United States
Two and one half years after stand-up, FDA’s Office of Pharmaceutical Quality is firmly established in it’s primary mission of assuring the quality and availability of safe and effective medicines to the public. The progression in organizational maturation allows a growing focus on innovative approaches to regulatory review and inspection in the agency’s ongoing efforts at continuous improvement and utilization of emerging technologies. This session will outline ongoing initiatives underway in OPQ and will provide the audience with access to selected OPQ senior leadership.
Learning Objective : Describe initiatives and implementation strategies related to the Product Quality Benefit/Risk Framework; Explain OPQ’s current view on science and risk-based policies and standards related to drug product quality; Discuss how FDA facilitates the adoption of emerging technology into pharmaceutical manufacturing.
Speaker(s)
A Regulatory Perspective on Science and Risk-Based Policies and Standards Related to Product Quality
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER
Panelist
Wendy Wilson-Lee, PHD
FDA, United States
Acting Branch Chief, Office of New Drug Products, OPQ, CDER
OPQ's Innovative Approaches For Facilitating the Adoption of Emerging Technology
Lucinda F. Buhse, PHD
FDA, United States
Director, Office of Surveillance, OPQ, CDER