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.

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.

Main roles and responsibilities are within the signal management activities in the EMA Pharmacovigilance Office; to conduct of ad-hoc queries and related data analyses based on requests from (Co)-Rapporteurs, EMA’s Scientific Committees and relevant Working Parties in the context of product related safety issues using EVDAS; to provide expert advice to EMA product teams on pharmacovigilance/signal detection and management issues; to support the implementation of the EV Access Policy and address requests related to access to information/documents from EV; to support the implementation of the Pharmacovigilance legislation. Rodrigo is co-chair of the EudraVigilance Expert Working Group.