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Wednesday, June 21 • 2:00pm - 3:15pm
#358: Life Cycle Management: ICH Q12

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

While the concepts in ICH Q8, Q9, Q10 and Q11 provided opportunities for a more science- and risk-based approach for assessing changes across the life cycle, several gaps exist which limit full realization of expected regulatory flexibility. These gaps include: harmonized change management best practices that effectively evaluates the impact of change on quality, clarity of the regulatory commitments (established conditions) in regulatory files and distinguishing them from supporting information, and the development and submission of product lifecycle management strategy in regulatory files. Effective lifecycle management remains a critical and visible focus for both regulators and the pharmaceutical industry.

This session will focus on the ICH Q12 draft guideline (Step 1 document). An EWG expert will describe in sufficient details the main chapters of Q12 draft guideline (Step 1 document),and proposed next steps.

Learning Objectives

Describe the scope, objectives and content of ICH Q12; Explain the linkage between ICH Q12 and the recently developed guidelines (ICH Q8, Q9, Q10 and Q11); Discuss the value of Q12 to streamline CMC life cycle management and simplify the regulatory process.


Moheb M. Nasr, PhD, MS


Technical and Regulatory Consideration of Pharmaceutical Product Life Cycle Management: ICH Q12
Andrew Chang, PhD

Roger Nosal

Sarah Pope Miksinski, PhD

Mahesh R. Ramanadham, PharmD, MBA

avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk A/S, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 25 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions. Andrew has served as a member of the planning committee for DIA annual conferences... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance, OPQ, CDER, FDA
Dr. Miksinski received her B.A. from Earlham College (1994) and her Ph.D. from Oklahoma State University (1999). She served as an NIH postdoctoral fellow from 2000-2002, and began as a CMC reviewer at the FDA in 2002. She is now the Acting Director of ONDQA/DNDQA 2.
avatar for Moheb Nasr

Moheb Nasr

Vice President, CMC Regulatory Strategy, GlaxoSmithKline
Dr. Nasr is responsible for the development and the execution of CMC regulatory strategy at GSK. Prior to joining GSK, he spent over 22 yrs at FDA and established and led the Office of New Drug Quality Assessment (ONDQA). Dr. Nasr was instrumental in the development of QbD concept... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... 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 →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Session
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  • Credit Type CME, IACET, RN
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