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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.

Chair

Christine M. V. Moore, PhD

Speaker

Facilitator
Nina S. Cauchon, PhD, RAC

Facilitator
Sarah Pope Miksinski, PhD

Facilitator
Eric Jayjock, PhD

Facilitator
Geoffrey Wu, PhD

Facilitator
Paul Seo, PhD


Speakers
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, External Advocacy and Standards, Organon & Co., United States
Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, with oversight for new GMP-related policy, analytical standards and compendial affairs. Christine started her career as a process development engineer, after which she moved to... 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

Deputy Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA, FDA, United States
Commander Geoffrey Wu, Ph.D., PMP, CPH, Deputy Office Director, Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), joined the FDA’s Office of Testing and Research (OTR) in 2010, has served as research scientist, science staff, chemistry reviewer, special... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Executive Director, CMC Regulatory Affairs, AstraZeneca, United States
Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently an Executive Director in CMC Regulatory Affairs. Her duties include leadership of a global team covering end to end CMC regulatory strategies, as well as serving as a key contributor to several ongoing... Read More →

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