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Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency
Session Chair(s)
Maria Cristina Mota Pina, MBA
Head, Regulatory Policy for Emerging Markets -Japan and Australia
AbbVie, United States
During this session, speakers will share insights and recent experiences regarding the implementation of Inspection Reliance from both Regulatory Authorities and Industry perspectives, including unilateral reliance and work-sharing.
Learning Objective : Understand Recent Trends in Reliance Applications for GMP Inspections and their impact on Supply Chain Sustainability; Explore Risk-Based Approaches for GMP Inspections by National Regulatory Authorities (NRAs); Learn about modalities and documentation required by Regulatory Authorities for Reliance in GMP Inspections; Share Regulatory Authorities and industry experiences.
Speaker(s)
Health Sciences Authority Singapore Perspective
Representative Invited
Health Sciences Authority Singapore, Singapore
Pathways to inspection reliance- a 20 year journey
Andrea Kurz
F. Hoffmann-La Roche Ltd, Switzerland
Senior Director, Lead External Advocacy Europe & Middle East
ANVISA Perspective
Bianca Zimon, LLM
ANVISA, Brazil
Health Regulation Specialist
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