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Grand Hotel San Marino

Dec 11, 2013 9:00 AM - Dec 13, 2013 10:00 AM

V. le A. Onofri, San Marino, 47890, San Marino

Electronic reporting of ICSRs in the EEA

Speakers

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.

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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