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10: RegCMC-Product Quality [clear filter]
Tuesday, June 25
 

2:00pm

#270: Where Quality Meets Safety and Efficacy: An Interactive Experience
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 Inc.
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. She is chair of the AAPS CMC Community, and in addition to AAPS is also active on the ISPE Expedited... 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

Global Head and Executive Director, GRACS CMC - Policy, Merck Research Laboratories
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
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Patient Focused,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Workshop

4:15pm

#299.1 CH: Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process
Component Type: Workshop
Level: Intermediate

Definition of the Regulatory Starting Material and its Impact on the Drug Substance manufacturing

Learning Objectives

Interpret the key elements for the designation of the regulatory starting material under ICH Q11 and describe its regulatory impact on the post approval changes in the global markets.

Chair

Xuhong Cheng, DrSc, PhD


Speakers
avatar for Xuhong Cheng

Xuhong Cheng

Associate Director, GRS - RA, Janssen, Pharmaceutical Companies of Johnson and Johnson
Xuhong holds a PhD degree in Organic Chemistry. She has eighteen years of pharmaceutical industrial experience including fourteen years of regulatory CMC for small molecule and biologic-pen injector combination products.


Tuesday June 25, 2019 4:15pm - 4:45pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA