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Virtual

Feb 17, 2022 1:30 PM - Feb 17, 2022 6:15 PM

(Central Europe Standard Time)

eXtended EudraVigilance Medicinal Product Dictionary for Sponsors virtual training course

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

Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

QPPV, PVpharm, Spain

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

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