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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
Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Panelist
Acting Branch Chief, Office of New Drug Products, OPQ, CDER , FDA, United States
OPQ's Innovative Approaches For Facilitating the Adoption of Emerging Technology
Director, Office of Surveillance, OPQ, CDER, FDA, United States
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