EMA guidance and EudraVigilance use to detect medication errors

Calin Lungu, Drug Development Consulting Services S.A., Windhof, Luxembourg (calinlungu@yahoo.co.uk)

The Eruopean Medicines Agency (EMA) has published several documents regarding the medication errors (Good practice guide on risk minimisation and prevention of medication errors, Good practice guide on recording, coding, reporting and assessment of medication errors). It has also held a workshop with the industry, the Heads of Medicines Agency and the Pharmacovigilance Risk Assessment Committee in 2013. The EMA hosts the European database of adverse drug reactions, EudraVigilance. This session will address the key aspects of the EMA guidance as well as will discuss the use and limitations of the EudraVigilance database in assessing medication errors, based on several examples.


Abstract Reference & Short Personal Biography of Presenting Author

Dr. Calin A. Lungu is the Chief Executive Officer of Drug Development Consulting Services (DDCS), a pharmacovigilance quality assurance consulting firm located in Windhof, in the Grand-Duchy of Luxembourg. He has worked for 15 years in drug development, clinical research, pharmacovigilance and quality assurance. Dr. Lungu has conducted a large number of pharmacovigilance audits for various pharmaceutical companies.

Dr. Lungu has been a Eudraviglance Trainer since 2004 and has trained more than 250 Eudravigilance and XEVMPD courses at the EMA, and also in the US and the EEA. He has also organised and presented 4 pharmacovigilance workshops in Romania and one in Croatia and has participated in various pharmacovigilance conferences in the EU.

Dr. Lungu 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, is currently training the use of EVDAS for MAHs and is performing EVDAS analysis for several MAHs.

Dr. Lungu is an active member of the DIA, the British Association for Research Quality Assurance (BARQA), the Belgian College of Pharmaceutical Physicians, the Belgian Association of Physicians from the Pharmaceutical Industry (ABEMEP) and various other non for profit organisations.

He graduated from the Free University of Brussels, Belgium and became MD in 1992, the same year he joined the pharmaceutical industry.

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