Dr Bert P Van Leeuwen

Global Pharmacovigilance Department

Astellas Pharma

Bert van Leeuwen MD is the deputy-QPPV of Astellas Pharma in Leiden, the Netherlands. His tasks, as a member of the 6 persons QPPV office, involve reviewing submissions to authorities (PSUR, DSUR, RMP, responses to questions and assessment reports) and being a member of several interdisciplinary teams e.g. in Signal Detection, Social Media, Protocol Review. For over 15 years he has been working in Pharmacovigilance. At first he was actively involved in the implementation of Core Safety Data Sheets, MedDRA and the setup of a Signal Detection system, as well as in large clinical trials. Then he led the Quality in PV group, implementing a Compliance Monitoring system and the PV Intelligence system and obtained experience in managing regulatory inspections. After a take-over he was active in the merger of the two PV Quality Document systems Publications Can Pharmacovigilance learn from the Oil & Gas Industry that has been outsourcing for over a century? Bert P. van Leeuwen, Christine Prendergast, Brian Edwards, Barbara Dawson Therapeutic Innovation & Regulatory Science DIA, (August 2016)