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Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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 Objectives

Identify Recent Trends in Reliance Applications for GMP Inspections and their impact on Supply Chain Sustainability; Describe Risk-Based Approaches for GMP Inspections by National Regulatory Authorities (NRAs); Discuss the modalities and documentation required by Regulatory Authorities for Reliance in GMP Inspections.

Chair

Maria Cristina Mota Pina, MBA

Speaker

Pathways to inspection reliance- a 20 year journey
Andrea Kurz

ANVISA Perspective
Bianca Zimon, LLM


Speakers
AK

Andrea Kurz

Senior Director, Lead External Advocacy Europe & Middle East, F. Hoffmann-La Roche Ltd, Switzerland
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
avatar for Bianca Zimon

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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