Sandra van Os

Background

About Sandra van Os

Experienced and results-driven pharmaceutical professional with a PhD from Radboud University, Nijmegen, and over 20 years of industry experience in the development of generic medicines.I combine strong scientific expertise with strategic leadership and operational insight, and have extensive experience in managing clinical and non-clinical development in compliance with GCP, GLP and GCLP. My strength lies in integrating formulation, analytical and clinical knowledge to drive efficient product development and achieve regulatory success across multiple global markets, while effectively balancing quality, cost, timelines and resource investment.Core competencies include:• Bioavailability and bioequivalence study design and execution• Applied pharmacokinetics, sample size calculation, statistical analysis and IVIVC• Biorelevant dissolution testing and biowaiver strategy development• Non-clinical and clinical safety evaluation and impurity qualification• Clinical and non-clinical outsourcing strategy, budgeting and vendor management• Risk-based monitoring, QMS development and regulatory documentation• Scientific advice strategy and interaction with regulatory authoritiesAs a pragmatic and communicative people manager, I lead international teams of Clinical Project Leaders, CRAs, CTAs and Toxicologists. I foster strong collaboration between internal experts and external partners, and regularly contribute as an invited speaker at international conferences.