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Tuesday, June 25 • 2:00pm - 3:15pm
#270: Where Quality Meets Safety and Efficacy: An Interactive Experience

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-626-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop will discuss patient-focus quality standards, also known as clinically-relevant specifications, and how it provides an approach to specification setting that is based on patient need, rather than manufacturing history.

Learning Objectives

Describe what is meant by patient-focused quality standards and how these approaches can impact specification setting and continual improvement efforts.


Christine M. V. Moore, PhD


Nina S. Cauchon, PhD, RAC

Sarah Pope Miksinski, PhD

Eric Jayjock, PhD

Geoffrey Wu, PhD

Paul Seo, PhD

avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
avatar for Eric Jayjock

Eric Jayjock

Director, Continuous Manufacturing, Patheon, A Part of Thermo Fisher Scientific
Eric Jayjock performed his graduate studies at Rutgers University where he was a part of the NSF Center for Structured Organic Particulate (C-SOPS) systems. During his time at Rutgers, one of his main areas of research was the development of scalable manufacturing processes for oral... Read More →
avatar for Christine Moore

Christine Moore

Executive Director, Organon & Co., United States
Christine Moore is Global Head and Executive Director, CMC Policy at Merck. Christine joined Merck after more than a decade in various positions in the US FDA. Prior to working at FDA, Christine spent 10 years in small and large molecule process development. Throughout her career... Read More →
avatar for Paul Seo

Paul Seo

Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA
Paul has worked for the FDA 15 years, and has gained experience in the Office of Generic Drugs, Office of Pharmaceutical Science, and Office of New Drug Quality Assessment. He currently oversees review processes in the Division of Biopharmaceutics, Office of New Drug Products, as... Read More →
avatar for Geoffrey Wu

Geoffrey Wu

Associate Director for Science and Communication, OLDP, OPQ, CDER, FDA, FDA
Commander Geoffrey Wu is a scientist officer in the United States Public Health Service. He is the Associate Director for Science & Communication in Office of Lifecycle Drug Products (OLDP), OPQ. He has been (co)leading quality assessment and research in controlled correspondence... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Senior Director, AstraZeneca

Tuesday June 25, 2019 2:00pm - 3:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Workshop
  • Level Intermediate
  • Featured Topics Patient Focused,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Workshop