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Session 6: Quality CMC/Harmonization
Session Chair(s)
Maria Guazzaroni Jacobs, PhD
Director, Quality Intelligence, Global Supply
Pfizer Inc, United States
This session will address challenges in the LA region on areas related to quality/CMC such as stability, importing testing, variations, dedicated facilities, and track and trace. There will be an opportunity for discussion with regulators at the panel discussion.
Speaker(s)
IFPMA/EFPIA Import Testing and Multi-product Facility Considerations
Maria Guazzaroni Jacobs, PhD
Pfizer Inc, United States
Director, Quality Intelligence, Global Supply
Challenges in Latin America on Stability Studies
Ana Padua, MSc, RPh
EMD Serono, Switzerland
Director EU Global Regulatory and Scientific Policy
Post-approval Changes
Maria Cristina Mota Pina, MBA
Latin America Federation of Pharmaceutical Industry (FIFARMA), United States
Director, Regulatory Policy and Intelligence -Japan, Emerging Markets, Australia
Tracking
Mark Paxton, JD, PhD
Rx-360, United States
President and CEO