Pharma Summit 2025

Quality Assurance Management Systems & Regulatory Affairs Director at PKNM Solutions Sàrl
Katerina holds a bachelor in Chemistry and PhD in Clinical Biochemistry. She succesfully executed 4-years PostDoc in EPFL in In Silico Pharmacology. She has an experience of more than 12 years in designing and implementing effective regulatory strategies, with precision for the design, development, implementation, verification and validation and clinical evaluation of Medical Devices, IVDs and medicinal products. She serves as an Auditor and Technical Assessor for EU Notified Bodies as per MDR, and as a Consultant to the IVD Prequalification Team of WHO