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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 - 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
Review Director, Office of Cellular and Tissue-based Products
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