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Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
Session Chair(s)
Theresa Mullin, PhD
Associate Center Director - Strategic Initiatives, CDER
FDA, United States
The session will provide an update on ICMRA's Pharmaceutical Quality Knowledge Management project, including an overview of learnings from the pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities.
Learning Objective : Describe the various workstreams of the ICMRA PQKM project, and their potential to support increased regulatory convergence and reliance with regards to product quality assessments and inspections; Summarise learnings arising from the ICMRA pilots on collaborative assessment of post-approval changes and hybrid inspections; Discuss potential for expansion and operationalization of the pilots.
Speaker(s)
Collaborative Assessment Pilot: Regulators’ Perspective
Sean Barry, PhD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor
Collaborative Assessment Pilot: Regulators’ Perspective
Sau L Lee, PhD
FDA, United States
Deputy Super Office Director, OPQ, CDER
Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Stelios Tsinontides, PhD, MA
FDA, United States
Office Director, OPMA, OPQ, CDER
Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Brendan Cuddy, MSc
European Medicines Agency, Netherlands
Lead Scientific Officer
Pilot Programs: Industry's Perspective
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Pilot Programs: Industry's Perspectives
Srivdya Srikant, MS
Gilead Sciences, United States
Director, Global Regulatory Affairs- CMC
Panel Discussion: Pilot Programs
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Panel Discussion: Pilot Programs
Yasuhiro Kishioka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer Director, Office of Cellular and Tissue-based Products
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