Françoise Sillan, I am a medical doctor as background working in pharmacovigilance pharma industry for 20 years. I am the Qualified Person for Pharmacovigilance (EUQPPV) for Sanofi. Before that, I worked in the vaccine pharmacovigilance for 15 years where I contributed to the development of standards definitions and methods through CIOMS WHO working groups on vaccine safety. I am a member of Pharmacovigilance committee at EFPIA, key EMA industry stakeholder, to facilitate pragmatic, consistent implementation of PV legislation and positively influence imminent changes to other legislation which are directly relevant to patient safety, transparency and provision of benefit risk information