Back to Agenda
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
Senior Pharmaceutical Assessor , Health Products Regulatory Authority (HPRA), Ireland
Collaborative Assessment Pilot: Regulators’ Perspective
Deputy Super Office Director, OPQ, CDER, FDA, United States
Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Office Director, OPMA, OPQ, CDER , FDA, United States
Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Lead Scientific Officer, European Medicines Agency, Netherlands
Pilot Programs: Industry's Perspective
Global Head International Regulatory Policy, Roche, Switzerland
Pilot Programs: Industry's Perspectives
Director, Global Regulatory Affairs- CMC, Gilead Sciences, United States
Panel Discussion: Pilot Programs
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Panel Discussion: Pilot Programs
Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Have an account?