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In Tuition House

Feb 18, 2019 9:00 AM - Feb 20, 2019 2:00 PM

210 Borough High Street, London, SE1 1JX, United Kingdom

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

Calin A. Lungu, MD

Calin A. Lungu, MD

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

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.

Lacramioara  Marcu

Lacramioara Marcu

Medical Director, DDCS S.A., Luxembourg

Dr. Lacramioara Marcu is the Medical Director of Drug Development Consulting Services (DDCS), a pharmacovigilance quality assurance consulting firm located in Windhof, Luxembourg. She has worked for 15 years in pharmacovigilance and quality assurance and has experience in EudraVigilance and XEVMPD, has conducted pharmacovigilance audits for various pharmaceutical companies, has audited transfer of safety databases and MedDRA recoding. Eudraviglance Trainer since 2017, Dr. Marcu has been a professional trainer in the use of the EudraVigilance Data Analysis System for European National Competent Authorities and the European Medicines Agency between 2008 and 2012. She is MD graduated from the Faculty of Medicine and Pharmacy, Romania in 1998.

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