The Workshop

POST-CONFERENCE WORKSHOP
Thursday 27th November 2008
Brian Raftery General Manager Dr. Oestreich & Partner		Dr. Uwe Lahr General Manager Dr. Oestreich & Partner
EDC and Query Management
Data management has evolved rapidly over the last few years and continues to do so. With the widespread use of EDC and the problems that this brings, the data management landscape for pharmaceuticals has never been more complex. This workshop is intended to providepractical hands-on sessions for practitioners to both share their experiences of EDC systems and query management and discuss common views of the changing nature, challenges and opportunities faced across the industry. We want participants to be as open as possible about the issues their companies face and be prepared to contribute to what promises to be a thought provoking workshop
Agenda
09.00	Registration
09.30	Session 1:	A day in the life of a query
10.00	Session 2:	Case Study: experiences with the handling of queries and their lifecycles
10.30	Session 3:	How system queries (classical edit checks), human queries (i.e. ‘post-its’) and Data Clarification Requests (DCRs) can be effectively managed together in the EDC environment
11.00	Refreshments
11.20	Session 4:	The realistic consequences/impact of EDC query management processes for site, clinical and data management personnel
11.50	Session 5:	Expected and unexpected queries: ‘safety’ management from the query management point of view
12.20	Session 6:	Fine tuning a study: using metadata for real-time improvement of data quality and the reduction of query creation
12.50	Close of workshop
About your workshop leaders:
Brian Raftery has over 20 years experience in the clinical trials field. Brian is a founding member and executive manager of Dr. Oestreich & Partner, and has been responsible for the in-house development of EDC software (OPVerdi) and related data management surveillance tools. Brian also has previous experience of teaching courses and workshops in EDC integration in the clinical trial environment. Dr Uwe Lahr carries over 14 years of experience in the pharma industry and is the Manager of New Business Development, CDISC implementation and Head of Data at Dr. Oestreich & Partner. Uwe has a scientific background and gained a PhD in Physics in 1992, going on to work at ORACLE in a variety of roles culminating in leading an international team to deliver training in ORACLE classrooms. Uwe joined Dr. Oestreich & Partner in 2005. Dr. Oestreich & Partner is an international CRO which specialises in Clinical Research, Software Solutions and Quality Assurance www.oandp-cro.com/cms.index.php