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Patient-Centric Development Assessment
Session Chair(s)
Mahesh Ramanadham, PHARMD, MBA
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States
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 Objective : Explain the importance of the target product profile to the life cycle of the product
Speaker(s)
Michael R. De Felippis, PHD
Senior Research Fellow, Biopharmaceutical Research and Development, Eli Lilly and Company , United States
Patient-Focused Biopharmaceutical Control Strategies
Diane J. Zezza
Vice President and Global Head, Regulatory CMC, Novartis Pharmaceuticals Corporation, United States
Incorporating Clinical Needs of Products into Quality Assessment
Mahesh Ramanadham, PHARMD, MBA
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States
Patient Centric Assessment
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