Michal Forstner-Dambenois has 17 years experience in the pharmaceutical industry in R&D and Drug Safety, most recently heading the European PV department of a large international pharmaceutical company with the responsibility to establish and maintain a compliant and high-performance PV system in all EU and non-EU countries, including Russia/CIS and Israel. Led the introduction of integrated risk management planning and the new EU-RMP process in a global PV organization, including development of RMP implementation processes and methods for the evaluation of effectiveness of risk minimization. Vast experience in the application of risk and benefit-risk analysis methodologies on pharmaceutical products and processes. Subject matter expert in drug safety issue and crisis management. Experience in auditing/QC monitoring of PV systems at the global, regional and local level, as well as experience as host and/or SME in regulatory authority inspections.