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Virtual

Oct 13, 2025 2:00 PM - Oct 17, 2025 6:30 PM

(Central Europe Standard Time)

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system. Check the - WHO SHOULD ATTEND - section for more information regarding course pre-requisites.

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.

Calin A. Lungu, MD

Calin A. Lungu, MD

CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg

Dr. Lungu has over 30 years of experience in pharmacovigilance and regulatory compliance. He has conducted 180+ PV audits for pharmaceutical companies and EU authorities, advised on PV system improvement, and supported EU inspections. Since 2004, he has been an official EMA EudraVigilance trainer, delivering 300+ global courses, and has served as EMA master trainer for the Clinical Trials Information System since 2021. He continues to train and support EVDAS use for MAHs. Dr. Lungu earned his MD from the Free University of Brussels in 1992.

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.

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