Since 2010, new pharmacovigilance legislation has been implemented in the European Union. Extensive guidance has been published and updated in light of a few year’s experience. GVP Module VI is by far the most extensive module and has been revised for a second time in July 2017.
This training course will present the most challenging aspects of GVP Module VI, with a focus on day-to-day practice, Quality Assurance and live demonstration of the EudraVigilance system, including EVWEB, XEVMPD and EVDAS.
Who is this course for?
This course is for anyone working in pharmacovigilance, Quality Assurance for pharmacovigilance, data entry personnel, personnel involved in signal management and electronic reporting of individual case safety reports (ICSRs), Qualified Persons for Pharmacovigilance (QPPVs).
Basic knowledge in pharmacovigilance and EudraVigilance is advisable.
- Direct reporting to EudraVigilance
- EMA Medical Literature Monitoring Services
- EudraVigilance Data Access Policy
- MAHs access to EVDAS
- ICSR download manager
- Data quality of ICSRs
- Preparation of inspections and audits with EudraVigilance
- Medication errors
- Status of the ISO IDMP standards implementation
This is a 1-day interactive workshop featuring a full day of focused lessons, discussions and live demonstrations. The day is tailored to the needs of the attendees and includes modules on the direct reporting to EudraVigilance, on the EMA Medical Literature Monitoring Services, on the EudraVigilance Data Access Policy, MAHs access to EVDAS, on EVWEB8 and the ICSR download manager, on data quality of ICSRs, on preparation of inspections and audits with EudraVigilance, medication errors and ISO IDMP standards.
At the end of the training, you will be able to:
- Understand the electronic current reporting requirements for ICSRs and medicinal products in the EU
- Understand the EudraVigilance system components and functionalities and how it can be usedto prepare audits and inspections
- Understand the EMA MLM service and the ICSR download
- Understand the EudraVigilance Data Access Policy
- Be familiar with EVDAS MAH version
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 worked for a biotechnology company since 1993, and since 1995, as an independent consultant. Since 1999, he founded Drug Development Consulting Services of which he is presently CEO and which provides services in the area of quality assurance for pharmacovigilance.
Dr. Lungu has conducted a large number of pharmacovigilance systems audits for various pharmaceutical companies, has audited transfer of safety databases and MedDRA recoding, PSUR processes, CCSI processes, signal detection, has participated in the preparation, conduct and follow-up of various regulatory inspections in the area of pharmacovigilance in Europe, has advised several EU and non-EU pharmaceutical companies in establishing/improving a pharmacovigilance system in conformity with current regulatory requirements.
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, Finland, Greece, France, Cyprus, Croatia, Hungary, Czech Republic, Poland, Portugal, San Marino, Austria, Sweden, Norway, Ireland, Romania, Germany, Spain, Lithuania. He has presented the ICH E2A and E2B guidelines in a seminar organised by the Food and Drug Administration in Thailand in 2005. He has also organised and presented 3 pharmacovigilance workshops in Romania and one in Croatia.
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 since 2008.
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.