Faculty
Raj Bains
Principal Consultant, Gxpconsult Limited, Germany
Raj has more than 20 years’ experience in post-authorisation and clinical trial pharmacovigilance. Since 2005, she is trainer for Eudravigilance and the Eudravigilance Product Dictionary courses. Raj is consultant member on the editorial board of the Regulatory Rapporteur Journal. She is a BSI qualified lead auditor for ISO 9001, a member of the Oxford Research Ethics Committee and the UK’s Health Research Authority Phase I Advisory Panel. She has a background in biochemistry and toxicology. Raj works as a consultant.
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.
Isabella Palagiano
Deputy QPPV/LCPPV, PVCS Line Manager, PVpharm, Spain
Isabella Palagiano graduated from Alma Mater Studiorum, University of Bologna with a master’s in Pharmacy&Pharmaceutical Industry. She is a PV professional with more than 5 years of experience on different positions across pharmacovigilance, with the main focus on ICSR Management, SPOR, EudraVigilance and XEVMPD set-up and maintenance, Deputy EU/UK QPPV activities, Local Contact Person for Pharmacovigilance, PSMF maintenance, audits/inspections and project management in post-marketing and clinical trials. From the beginning of her career, she has been involved in the maintenance of the XEVMPD and EudraVigilance operations for both Sponsors and MAHs.
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