Boehringer Ingelheim's Andy Lawton on TransCelerate BioPharma and Risk-Based Monitoring
At a recent risk-based monitoring (RBM) conference in Cambridge, Medidata's RBM expert Steve Young caught up with Andy Lawton, global head of clinical data management at Boehringer Ingelheim and a member of TransCelerate's RBM workstream. Andy, along with Sanofi's RBM lead Lori Convy, led a panel discussion providing an industry update on TransCelerate BioPharma and their RBM plans for 2014. Andy additionally gave a presentation focused on the Integrated Quality and Risk Management Plan (IQRMP), a key component of RBM planning that is not only described in TransCelerate's position paper but also referenced in FDA's draft RBM guidance and the EMA RBM reflection paper. In this video recap, Andy and Steve discuss best practices around the IQRMP, the need for transparency and more.
*Guest blogger Andy Lawton is global head of clinical data management, at Boehringer Ingelheim, based in Berkshire, England.