DINNER SHORT COURSES

Monday, May 9 | 5:30 – 8:30 pm

SC1: Meeting the Customers’ Needs. What Are the Expectations of Risk-Based Monitoring?*

The focus of this workshop will be on the main different customers (sites, investigators, monitors, sponsors, etc.) and what we should be doing to satisfy them. The basics of risk-based monitoring have been demonstrated to work, so we will start with the “customer’s” expectations, some just assumed and others in guidance, etc.

Instructors:

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

Andy Lawton joined BI 28 years ago. Andy is responsible for managing the statistics, data management and programming groups with BIs UK operation. The group has specialised in the management of large scale trials and the implementation of risk based approaches within them. His experience covers over 33 years in clinical trials, but he also has extensive experience in the areas of computing, statistics, Data Management, RDE and system design. Andy was a founding Committee Member of ACDM and aided in the initiation of CDISC with the provision of the business model. Before joining BI, Andy worked as a statistician in the NHS and in computing in a geophysical exploration company.

Jean Baumann, Change Management Specialist, JMB Consulting, LLC

*Separate registration required.