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Virtual

Feb 21, 2024 9:00 AM - Feb 23, 2024 1:00 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

Monika  Gappa

Monika Gappa

Pharmacovigilance Officer, PVpharm, Spain

Monika Gappa is a Pharmacovigilance professional with a degree in Pharmacy from Medical University in Gdansk, Poland. She has 6 years of expertise in PV with a wide background in the fields of XEVMPD and EudraVigilance set-up and maintenance. Additionally, she has managed local, global and regulatory intelligence projects as well as supported Health Authority inspections and client audits. Since 2020, she is the PV Network Coordinator of Local Contact Persons for Pharmacovigilance for more than 25 countries. It is the broad range of experiences that gives Monika a different perspective on the industry she works in.

Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

CEO, 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.

Vojtech  Kvita

Vojtech Kvita

Executive Director, NextPV Services, Czech Republic

Vojtech is a qualified expert in drug safety and pharmacovigilance with extensive experience gained through working on different positions across all PV areas. The wide exposure to global clients (both sponsors and MAHs) has helped him to gain a comprehensive overview of critical PV processes and systems. Vojtech’s main expertise is advance pharmacovigilance consulting, EU QPPV activities, signal management, ICSR management, EudraVigilance support, XEVMPD/ISO IDMP, PV auditing and medical writing.

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