Andy Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, RBA in CSV and clinical trials. He is currently consultant and director of Risk Based Approach Ltd. Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim were he also held positions of increasing responsibility during his 30 years with BI. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publication is the paper with Dr. Alistair Ross on GP Audit - throughout 80's and 90's this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and central monitoring in the TIRS Journal.