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European Medicines Agency

May 14, 2014 9:00 AM - May 16, 2014 5:00 PM

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

EudraVigilance - electronic reporting of ICSRs

Speakers

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.

Enrico  Marchesi, PhD

Enrico Marchesi, PhD

Pharmacovigilance Consultant, Independent, Italy

Graduated in Biological Sciences at the University of Pavia. Since 1969, he covered various roles, including Project Leader in clinical research, in major Italian and International pharmaceutical companies. In 1993, he set up the Italian PhV Unit of Schering-Plough and in 1998 he became the QPPV for Schering-Plough Europe based in the UK, position that maintained until retirement. Teacher at the Master in Pharmacovigilance at the University of Milan since 2003 and EMEA official trainer for Eudravigilance since 2004. At present, he works as PhV Consultant for multi-national clients. As QA, he is performing system, process and due diligence audits. He is also author of numerous publications in Italian and international journals.

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