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Virtual

Apr 09, 2025 2:00 PM - Apr 11, 2025 6:30 PM

(Central Europe Standard Time)

eXtended EudraVigilance Medicinal Product Dictionary Training Course

Virtual training course on how to submit and retrieve medicinal product data using EVWEB/ XEVMPD (Art 57 database) for authorised as well investigational medicinal products.

Faculty

Jan  Kolouch, PharmD

Jan Kolouch, PharmD

CEO, Strategic PV Advisor, NextPV Services s.r.o., Czech Republic

PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.

Isabella  Palagiano

Isabella Palagiano

, PVpharm, Spain

Isabella Palagiano graduated from Alma Mater Studiorum, University of Bologna with a master’s in Pharmacy&Pharmaceutical Industry. She is a PV professional with more than 5 years of experience on different positions across pharmacovigilance, with the main focus on ICSR Management, SPOR, EudraVigilance and XEVMPD set-up and maintenance, Deputy EU/UK QPPV activities, Local Contact Person for Pharmacovigilance, PSMF maintenance, audits/inspections and project management in post-marketing and clinical trials. From the beginning of her career, she has been involved in the maintenance of the XEVMPD and EudraVigilance operations for both Sponsors and MAHs.

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