Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual Training Course using the EudraVigilance System
Calin A. Lungu, MD
- Drug Development Consulting Services S.A. (DDCS), Luxembourg
Dr. Lungu has worked for 15 years in drug development, clinical research, pharmacovigilance and quality assurance. Since 2004 he is a EudraVigilance trainer and trained more than 250 Eudravigilance and XEVMPD courses at the EMA, selected European cities and also in the US. He has also trained from 2008 to 2012 the EudraVigilance Data Analysis System course at the EMA and including participants from the EMA and the National Competent Authorities.
Jose Alberto Ayala Ortiz
- PVpharm, Spain
José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2003, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.