戻る Agenda
Life Cycle Management: ICH Q12
Session Chair(s)
Moheb M. Nasr, PHD, MS
Principal
Nasr Pharma Regulatory Consulting, United States
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 Objective : 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.
Speaker(s)
Technical and Regulatory Consideration of Pharmaceutical Product Life Cycle Management: ICH Q12
Andrew Chang, PHD
Novo Nordisk, United States
Vice President, Quality and Regulatory Compliance
Panelist
Roger Nosal, PHD
Pfizer Inc, United States
Vice President, Head of Global CMC
Panelist
Sarah Pope Miksinski, PHD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Panelist
Mahesh R. Ramanadham, PHARMD, MBA
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER