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Session 1: Life Cycle Management
Session Chair(s)
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair
Luxembourg
Moheb M. Nasr, PhD, MS
Principal
Nasr Pharma Regulatory Consulting, United States
The concepts described in ICH Q8, Q9, Q10 and Q11 provide opportunities for a more science- and risk-based approach for developing medicinal products. However full implementation of these concepts have not been realized mainly with regards to assessing changes across the life cycle of pharmaceutical products. Several gaps exist which limit intended benefits: criteria for a harmonized risk-based change management system that effectively evaluates the impact of change on quality, clarity of the expectations of a knowledge management system that ensures continuity of product and process information, and appropriate level of detail and information sufficient for regulatory assessment and inspection.
Leading regulators, from Europe and the United States, will join industry speakers to share their perspectives on this topic and provide an update on progress made to date. Presentations will be followed by panel discussions.
Speaker(s)
Life Cycle Management - ICH Q12
Moheb M. Nasr, PhD, MS
Nasr Pharma Regulatory Consulting, United States
Principal
Life Cycle Management - Industry Perspective and Case Studies
Ganapathy Mohan, PhD
Merck & Co., Inc., United States
Head of External Affairs (Quality)
Life Cycle Management - EU Perspective
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
Life Cycle Management - FDA Perspective
Robert Iser, MS
Genentech, A Member of the Roche Group, United States
Lead, Quality Policy and Advocacy, Pharma Technical Quality and Compliance
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