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BCN Amsterdam Arena

Jun 17, 2019 9:00 AM - Jun 19, 2019 2:00 PM

Hoogoorddreef 5, 1101 BA Amsterdam, Netherlands

The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format

This hands-on training covers the functionalities of the new EVWEB application, practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format.

Faculty

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.

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.

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