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Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management
Session Chair(s)
Michael McDonald, PHD
Programme Manager, Office of the Chief Executive
Health Products Regulatory Authority, Ireland
The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQKMS) project is enabling greater regulatory and manufacturing agility to address issues impacting supply and availability of medicines. This session from ICMRA regulators will provide an update on the latest progress made within the project.
Learning Objective : Describe the latest developments in the ICMRA Pharmaceutical Quality Knowledge Management (PQKM) project, including workstreams within ICMRA, ICH, IPRP and PIC/S to support a PQKM capability; Discuss the long-term potential for the PQKM project to enable a global pathway for submission and assessment of CMC post-approval changes, thereby supporting greater regulatory harmonisation and reliance.
Speaker(s)
Panelist
Brendan Cuddy, MSC
European Medicines Agency, Netherlands
Lead Scientific Officer
Panelist
Stephen Mahoney, JD, MS
Gilead Sciences, United States
Head of Quality Policy and Advocacy
Supporting regulatory convergence and reliance through Pharmaceutical Quality Knowledge Management
Theresa Mullin, PHD
FDA, United States
Associate Center Director - CDER
PQKM collaborative assessment pilot programme - Regulator's perspective and udpates
Sean Barry, PHD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor
PQKM pilot programmes – Industry perspective
Susanne Ausborn, PHD
Roche, Switzerland
Global Head International Regulatory Policy
Panelist
Evdokia Korakianiti, PHD, MSC
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
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