Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges

Natalia holds a PhD in Pharmacy from the University of Medical Sciences of Costa Rica and a Master's degree in Drug Research, Development and Innovation from the University of Navarra. With a strong background in business development, Natalia previously worked in a preclinical CRO, where she excelled in driving growth and establishing strategic alliances. Her career also includes outstanding contributions as Medical Sales Representative in different companies, such as Abbott. In addition, Natalia has valuable experience in quality assurance from her time at Pfizer and other pharmaceutical manufacturing sites, ensuring compliance with industry standards.

 

Javier holds a degree in Chemistry and a Master’s in Drug Discovery. He began his career in public research, focusing on the synthesis and structural characterization of cannabinoids, gaining valuable experience in organic chemistry and analytical techniques, moving later to the pharmaceutical industry focusing method validation and risk assessment of extractables and leachables (E&L) and elemental impurities in accordance with ICH Q3D guidelines.