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[V3-S1] Expectations for ICH Q12
Session Chair(s)
Haruhiro Okuda, PhD
Deputy Director General, National Institute of Health Sciences, Japan
ICH Q12 is a guideline on technical and regulatory considerations for pharmaceutical product life cycle management. This guideline will focus on activities after approval, especially on how to proceed change control processes effectively. For global companies, the difference of the change control processes among countries prevents continuous improvements and innovations. While ICH Q12 is still under development, we would like to take this opportunity to share expectations on this new guideline from EU, FDA, and PMDA.
Speaker(s)
Moheb M. Nasr, PhD, MS
Principal, Nasr Pharma Regulatory Consulting, United States
ICH Q12 – Progress Update
Yasuhiro Kishioka, PhD
Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
ICH Q12 (Pharmaceutical Product Life Cycle Management): PMDA Perspective
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair, Luxembourg
EU Perspective on ICH Q12
Mahesh Ramanadham, PharmD, MBA
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States
FDA Perspectives on ICH Q12