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Virtual

Dec 04, 2023 9:00 AM - Dec 08, 2023 1:30 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 and principles of EVDAS.

Faculty

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.

Ana  Araujo

Ana Araujo

ADR Monitoring Unit-National Pharmacovigilance Centre, Infarmed, Portugal

Ana has worked 13 years in the Directorate of Risk Management for Medicines of the Portuguese medicines competent authority INFARMED. Until 2013, she was Responsible Person for EudraVigilance and member of the EudraVigilance Expert Working Group and EudraVigilance Telematics Implementation Group. Between 2013 and 2015, Ana was INFARMED’s Executive Board adviser responsible for managing the National Pharmacy and Therapeutic Committee. Since 2015, she has been working with consumption and prescription data on medicinal products, analysing trends in medicines’ prescription and use in Portugal. Ana has extensive experience as a trainer in pharmacovigilance and EudraVigilance since 2003.

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