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Alternative GMP/GDP Inspection Practices: Opportunities implementing Lessons Learned from a Pandemic Situation (COVID-19)
Session Chair(s)
Judit Fernandez Fernandez
Scientific Officer
European Medicines Agency, Netherlands
Stephan Roenninger, DrSc
Director, Quality External Affairs
Amgen (Europe) GmbH, Switzerland
Complying with regulatory processes and ensuring continuous supply can be a challenge especially during crises such as the COVID-19 pandemic. Valuable experience had been gained with alternative approaches to on-site inspections. Added value is demonstrated in retaining these practices beyond the pandemic situation. Reality demonstrated that reliance and recognition is possible while utilizing expertise from local inspectorates. Tools available from the Pharmaceutical Inspection Corporation Scheme (PIC/S) provided the basis to perform Remote Desktop Reviews as distant assessments in a coordinated way. These presentations will also demonstrate the pros and cons from paper-based and e-technology enabled inspections. Lessons learned for both pre-approval and routine inspections could be permanently implemented, in compliance with existing legislation.
Learning Objective : Discuss experience with alternatives to onsite inspections and evaluate the feasibility to retain some best practices beyond the pandemic situation as enablers for efficient and effective use of resources, accelerating approvals and international reliance / recognition.
Speaker(s)
Introduction: Current Issues in Inspection Management
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
GMP Inspection During Covid-19: EMA Perspective
Judit Fernandez Fernandez
European Medicines Agency, Netherlands
Scientific Officer
Real-Time Remote Inspections Pilot
Cristina Baccarelli, MSc
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
GMP Inspector
Experience on Virtual Inspection From the PIC/S Perspective
Anne Hayes
Health Products Regulatory Authority (HPRA), Ireland
IInspection Manager, Compliance Department
Industry Position on Virtual Inspections
Søren Pedersen
Novo Nordisk A/S, Denmark
Senior Director External Affairs
WHO Perspective
Joey Gouws, PhD, MPharm
World Health Organization, South Africa
Director, Inspectorate & Law Enforcement, South African Department of Health
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