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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)
Sean Barry, PHD
Senior Pharmaceutical Assessor , Health Products Regulatory Authority (HPRA), Ireland
Collaborative Assessment Pilot: Regulators’ Perspective
Sau Lee, PHD
Deputy Super Office Director, OPQ, CDER, FDA, United States
Collaborative Assessment Pilot: Regulators’ Perspective
Stelios Tsinontides, PHD, MA
VP, QMS, Transformation, and External Advocacy, Merck, United States
Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Brendan Cuddy, MSC
Lead Scientific Officer, European Medicines Agency, Netherlands
Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
Pilot Programs: Industry's Perspective
Srivdya Srikant, MS
Director, Global Regulatory Affairs- CMC, Gilead Sciences, United States
Pilot Programs: Industry's Perspectives
Evdokia Korakianiti, PHARMD
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Panel Discussion: Pilot Programs
Yasuhiro Kishioka, PHD
Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panel Discussion: Pilot Programs
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