Bert Van Leeuwen | Senior Director, Deputy QPPV
Astellas Pharma Europe BV

Bert van Leeuwen is the deputy-QPPV of Astellas Pharma. After obtaining his MD he worked in various hospitals for several years. Now working in Pharmacovigilance for over 20 years, he started at Organon leading two Therapeutic Areas, both for marketed products as well as clinical trials, in a quickly growing PV department; he was also closely involved with the implementation of Core Safety Data Sheets, MedDRA and the setup of a Signal Detection system. Thereafter he led the ‘Quality in PV’-group, implementing a Compliance Monitoring system and the PV Intelligence system as well as managing regulatory inspections. After the take-over by Schering-Plough he was actively involved in merging the two PV Quality Document systems. Then moving to Astellas, he led one of the two Therapeutic Groups in PV, before accepting his current role. As deputy-QPPV, a lot of time is devoted to review and approval and managing oversight of the PV system; next to this he is actively involved in the Signal Management group, the Digital Governance Steering Group, several improvement initiatives and Quality Document updates, audits and inspections. Next to the daily work he attended many conferences globally since 2000, some as a speaker, most of the time about PV Legislation, Signal Detection and PV Outsourcing;. For 6 years he was an active member of a group of PV professionals working on a standard for PV outsourcing; several publications were the result.