Loading…
← Back to schedule
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

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.

Chair

Maria Cristina Mota Pina, MBA

Speakers
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie
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 →
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

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share
Share Modal

Share this link via

Or copy link