Mary Arnould is Director, Center of Excellence & RBM Lead at Astellas Pharma and has been at Astellas over 3 years. She has over 25 years of clinical operations and site monitoring management experience, focusing on RBM implementation since 2014. Mary is currently leading RBM implementation and the Clinical Compliance Team at Astellas. Her vast clinical operations and monitoring experience has allowed her to help evolve the risk-based approach implemented at Astellas exploring ways to evaluate effectiveness, promote adaptability, leverage technology, and enhance processes to meet the challenges presented by the current pandemic. Mary is an active member in the TransCelerate RBM work stream.

Stuart has over 20 years pharmaceutical experience within Biometrics and Data Management. He has contributed to many regulatory submissions and inspections during this time. Stuart has been working on the implementation of Risk Based Monitoring at Boehringer Ingelheim since 2013 and assumed responsibility as the global lead of this project in 2016. Stuart currently resides in Connecticut.