Marion’s Bio: Marion Wolfs is a senior leader within the Integrated Data Analytics and Reporting (IDAR) organization from Janssen Pharmaceutical Companies of JnJ. In this role she is responsible for the oversight, execution, and management of the Analytical Risk-Based Monitoring (ARBM) processes including beyond trial level risk analysis at Janssen. She has been an RBM workstream co-lead for TransCelerate from 2016 till 2019 and is currently co-leading the RBM working group at PHUSE. Marion joined the pharmaceutical industry in 2007 and worked in various clinical operations roles until joining the Risk Management-Central Monitoring Group in October 2014. Marion holds a Master of Science degree in Biomedical Sciences from the Maastricht University and an International Certificate in Enterprise Risk Management from IRM.