Agnieszka Czapko
Agnieszka serves as the Head of the Regulatory and Start-up Department at Pure Clinical. She oversees feasibility assessments, clinical site recruitment and cooperation, as well as coordination of clinical studies evaluating the performance of IVD medical devices. She supports research teams throughout the entire study process — from the preparation of documentation compliant with ICH-GCP, ISO 20916:2019, IVDR 2017/746, and FDA requirements, to obtaining ethical and regulatory approvals. She holds a degree in Biotechnology and Environmental Protection from the University of Warsaw, specializing in microbiology. Her professional background includes work as a microbiology specialist in pharmaceutical companies, where she co-authored and reviewed scientific publications. Agnieszka is currently pursuing postgraduate studies in Clinical Trial Management and Monitoring at Kozminski University in Warsaw.
Agnieszka Czapko
Education (3)
Kozminski University in Warsaw
Postgraduate Studies in Clinical Trial Management and Monitoring
2023–2024
University of Warsaw
Master's degree, Environmental Protection
X 2002 – IX 2007
University of Warsaw
Master's degree, Biotechnology / Microbiology
X 2003 – IX 2008
Work Experience (5)
Pure Clinical
Head of Regulatory & Startup Department
V 2025 – currently
Senior Clinical Affairs Specialist
V 2023 – IV 2025
Clinical Affairs Specialist
II 2022 – IV 2023
University of Warsaw
PHD Student
X 2018 – II 2022
ZF Polpharma SA
Quality Control Specialist
IX 2013 – VI 2015
Publications (3)
Antibiotics and Antibiotic Resistance Genes in Animal Manure – Consequences of Its Application in Agriculture. Front. Microbiol., 29 March 2021 | https://doi.org/10.3389/fmicb.2021.610656
The impact of environmental contamination with antibiotics on levels of resistance in soil bacteria. J Environ Qual. Sep-Oct 2010;39(5):1679-87. doi: 10.2134/jeq2009.0499.