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Name
Katarina Petrasova
Title
Associate Director of Regulatory Affairs, MAA and Maintenance
Bio
In PrimeVigilance, Katarina currently serves as the Associate Director of Regulatory Affairs, MAA and Maintenance Unit, where she offers senior oversight for projects involving marketing authorization applications (MAA) and a broad spectrum of post- authorization product lifecycle activities.
Since joining the company in 2013, Katarina has systematically built hands-on expertise, navigating through diverse roles from medical writing to regulatory affairs, working on preparation, compilation, and submission of MA dossiers, managing variations or notifications, and establishing effective liaison with industry stakeholders and National Competent Authorities, ensuring strict alignment with regulatory requirements and market strategy.
On the local level, Katarina acts as the Local Contact Person for Regulatory Affairs (LCPRA) with the State Institute for Drug Control in the Czech Republic. Furthermore, her duties include serving as the Local Contact Person for Pharmacovigilance (LCPPV) and as the Person Responsible for Local Screening (PRLS).
In terms of education, Katarina holds a Master’s Degree in Natural Sciences, specializing in Immunology, from Charles University in Prague.
Since joining the company in 2013, Katarina has systematically built hands-on expertise, navigating through diverse roles from medical writing to regulatory affairs, working on preparation, compilation, and submission of MA dossiers, managing variations or notifications, and establishing effective liaison with industry stakeholders and National Competent Authorities, ensuring strict alignment with regulatory requirements and market strategy.
On the local level, Katarina acts as the Local Contact Person for Regulatory Affairs (LCPRA) with the State Institute for Drug Control in the Czech Republic. Furthermore, her duties include serving as the Local Contact Person for Pharmacovigilance (LCPPV) and as the Person Responsible for Local Screening (PRLS).
In terms of education, Katarina holds a Master’s Degree in Natural Sciences, specializing in Immunology, from Charles University in Prague.
