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Wednesday, June 21 • 4:00pm - 5:15pm
#385: Patient-Centric Development Assessment

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

Patient-centric product quality requires that patient needs are incorporated effectively during product development and assessment activities. Establishing a Target Product Profile is essential to the design and control of a product platform in order to accommodate and deliver patient needs throughout the product life cycle. As well, incorporating patient centric needs into product quality assessment ensures outcomes that are risk based and balanced. This session will explore industry and agency practices and expectations in implementing patient-centric product quality development and assessment approaches.

Learning Objectives

Explain the importance of the target product profile to the life cycle of the product

Chair

Mahesh R. Ramanadham, PharmD, MBA

Speaker

Patient-Focused Biopharmaceutical Control Strategies
Michael R. De Felippis, PhD

Incorporating Clinical Needs of Products into Quality Assessment
Diane J. Zezza

Patient Centric Assessment
Mahesh R. Ramanadham, PharmD, MBA


Speakers
avatar for Michael De Felippis

Michael De Felippis

Senior Research Fellow, Biopharmaceutical Research and Development, Eli Lilly and Company
Michael R. De Felippis joined Eli Lilly and Company in 1990 after obtaining his doctorate in biochemistry at The Ohio State University. He is currently a Senior Research Fellow in the Biopharmaceutical Research and Development division. His work is focused on commercializing biopharmaceutical... Read More →
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Division Director (Acting), Div. of Inspectional Assessment, OPF, OPQ, CDER, FDA
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →
avatar for Diane Zezza

Diane Zezza

Vice President and Global Head, Regulatory CMC, Novartis Pharmaceuticals Corporation
Diane Zezza is Vice President and Global Head Regulatory Affairs, CMC at Novartis Pharmaceuticals. Diane has global responsibilities for CMC regulatory strategies/submissions for all development and lifecycle products. Diane has been a speaker at conferences on regulatory topics including... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm
N426c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Session
  • format json
  • Credit Type CME, IACET, RN
  • Tags Session