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Virtual

Jun 15, 2026 2:00 PM - Jun 19, 2026 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

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.

Raj  Bains

Raj Bains

Principal Consultant, Gxpconsult Limited, Germany

Raj has more than 20 years’ experience in post-authorisation and clinical trial pharmacovigilance. Since 2005, she is trainer for Eudravigilance and the Eudravigilance Product Dictionary courses. Raj is consultant member on the editorial board of the Regulatory Rapporteur Journal. She is a BSI qualified lead auditor for ISO 9001, a member of the Oxford Research Ethics Committee and the UK’s Health Research Authority Phase I Advisory Panel. She has a background in biochemistry and toxicology. Raj works as a consultant.

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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