|
Natasha Yefimenko Scientific Study Manager Email: |
Background
Natasha Yefimenko is a Senior Programme Manager specialising in biomedical research, with a strong track record of coordinating complex initiatives under IMI JU, Horizon, EMA, and EIT Health frameworks. She holds a PhD in Biomedicine and brings extensive expertise in the coordination and management of multinational, observational pharmacoepidemiological studies and biomedical research projects—both clinical and non-clinical—in areas such as neurodegenerative, respiratory, and oncological diseases.
She has successfully led large-scale public-private partnerships involving pharmaceutical companies, regulatory agencies, academic institutions, and healthcare non-profits, guiding projects from inception through to sustainable implementation. Her strong foundation in regulatory intelligence and quality management in pharmacovigilance and pharmacoepidemiology enables her to navigate complex healthcare environments with precision. With advanced regulatory writing capabilities, she contributes to the preparation of high-quality documentation for regulatory submissions, supporting compliance, safety, and effectiveness in a rapidly evolving healthcare landscape. She also contributes to the scientific community as an Editorial Board Member for Frontiers and a reviewer for Springer Nature.
Publications
- Unlocking real-world evidence in post-marketing surveillance: The critical role of scientific management. (2024). White Paper.
- Quality compliance while conducting NIS studies: Critical success factors assessment and the use of key performance indicators. (2023). ICPE.
- The challenges and lessons learnt from conducting COVID-19 monitoring studies through VAC4EU: Coordination and management perspective. (2023). ICPE.
- Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries. (2023). ICPE.
- Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data: Methods and results of the first study feasibility assessment. (2023). ICPE.
- The impact of COVID-19 on population-level drug utilisation of alendronate in five European countries: An interrupted time series analysis. (2023). WCO.
- VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in four European countries: Study design and first results. (2022). ISPE.
- Conducting observational multi-country studies for regulatory decision making during the COVID-19 pandemic: The strategic role of the scientific study manager. (2022). ISPE.
- AMPAR/TARP stoichiometry differentially modulates channel properties. (2020). Nature Communications.
- Real-world evidence multi-database research in Europe: The EU-ADR Alliance. (2019). ICPE.
- Mechanisms of CPT1C-dependent AMPAR trafficking enhancement. (2018). Frontiers in Molecular Neuroscience.
- Ionotropic glutamate receptors trafficking in health and disease. (2017). Frontiers.
- Novel regulation of the synthesis of AMPA receptor subunit GluA1 by carnitine palmitoyltransferase 1C (CPT1C) in the hippocampus. (2015). The Journal of Biological Chemistry.
- AMPAR interacting protein CPT1C enhances surface expression of GluA1-containing receptors. (2015). Frontiers in Cellular Neuroscience.
- The AMPA receptor modulator S18986 in the prelimbic cortex enhances acquisition and retention of an odor-reward association. (2013). Neuroscience Letters.
Teaching
- Teaches on regulatory writing, regulatory intelligence, quality assurance and processes in RWE research and multistakeholders healthcare projects