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Monday, June 19 • 11:00am - 12:15pm
#128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Patrick Ricucci, PMP

Speaker

A Regulatory Perspective on Science and Risk-Based Policies and Standards Related to Product Quality
Laurie Graham

Panelist
Wendy Wilson-Lee, PhD

OPQ's Innovative Approaches For Facilitating the Adoption of Emerging Technology
Lucinda F. Buhse, PhD


Speakers
avatar for Lucinda Buhse

Lucinda Buhse

Director, Office of Testing, OPQ, CDER, FDA
Dr. Buhse joined OTR in 2001 as Deputy Director of Division of Pharmaceutical Analysis. She was promoted to Division Director in 2004 and has been Director of Office of Testing and Research since 2013. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical... Read More →
LG

Laurie Graham

Acting Director, DIPAP, OPPQ, OPQ, CDER, FDA
Ms. Graham is the Acting Directorof the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.
avatar for Patrick Ricucci

Patrick Ricucci

Associate Director of Regulatory Affairs (Acting), ONDP, OPQ, CDER, FDA
Patrick is the acting Associate Director of Regulatory Affairs in the Office of New Drug Products (ONDP) within FDA’s Office of Pharmaceutical Quality. He’s also a certified Project Management Professional (PMP). Patrick is intricately involved in ONDP efforts such as strategic... Read More →
avatar for Wendy Wilson-Lee

Wendy Wilson-Lee

Acting Branch Chief, Office of New Drug Products, OPQ, CDER, FDA
Wendy is an acting Branch Chief in the Office of New Drug Products, bringing 10 years of review experience to the position. She has a B.S. in Chemical Engineering as well as a B.S. in Chemistry from North Carolina A&T State University. She earned her Ph.D. in Pharmaceutical Science... Read More →

Monday June 19, 2017 11:00am - 12:15pm
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Forum
  • format json
  • Credit Type CME, IACET, RN
  • Tags Forum