e-Clinical Trials 2008

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Pre-conference workshop
Monday 19 May 2008	Led by Mats Sundgren PhD, Principal Scientist, Clinical Information Strategy, Global Clinical Development ASTRAZENECA	Opportunities and challenges: the use of EHRs for secondary use
About the Workshop
The purpose of this workshop is to increase the understanding of EHRs and their potential wider use. Through interactive discussion, Mats Sundgren will discuss EHRs from not only a technical perspective, but also a broader perspective. He will explore the social, legal and ethical issues raised by the use of EHRs for other medical purposes, including research, and will present findings and recommendations from the Efpia’s task force on EHR.
Workshop agenda
13:30	Delegate registration and coffee
14:00	Sessions will explore the following key issues Global overview of trends, definitions and penetration of EHR Interaction model, legal aspects and issues in the EU Impact areas of EHR for secondary use in the pharmaceutical industry (e.g. EDC-EHR integration, patient recruitment, drug safety monitoring) Overview of 3 pilot projects from Efpia as the basis for concrete recommendations (core data sets, third party assessment, standards service for patient recruitment) Status of EU initiatives and discussion of opportunities and challenges
16:30	Close of workshop
About your Workshop leader
Mats Sundgren	Mats Sundgren, PhD, Principal Scientist, works at AstraZeneca Global Clinical Development. He has more than 20 years’ experience in the pharmaceutical industry and has, for the last six years, been working in the area of medical informatics and clinical information strategy. He is also a member of Efpia EHR task force.
About AstraZeneca
AstraZeneca	AstraZeneca is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in important areas of healthcare. They are active in over 100 countries with growing presence in important emerging markets. Their sales in 2006 totalled $26.5 billion, with an operating profit of $8.2 billion.



Post-conference workshop
Thursday 22 May 2008	Led by Dr Andy Richardson and Dennis Wächter ADH SOLUTIONS	Turning EDC requirements into implemented solutions: key methods for design and specification
About the workshop
Realising the potential of EDC for any particular study requires the creation and validation of the e-trial systems before the first patient’s first visit. This puts the technical team firmly on the project’s critical path with all the timeline pressures that this brings. The key factors to successful system implementations are confirmed requirements and efficient testing. This workshop will present techniques to develop and confirm EDC specifications, and delegates will discuss how these can be used to support the build and validation processes.
Workshop agenda
09:30	Delegate registration and coffee
10:00	Sessions will explore the following key issues The problem: turning the protocol into a product Techniques for developing consistent and efficient EDC specifications generic customised data sources and workflows Supporting the EDC implementation and validation In practice: examples and exercise Discussion and Q&A
12:30	Close of workshop
About your workshop leaders
Dr Andy Richardson	Dr Andy Richardson originally trained in pharmacology and has worked in the pharmaceutical and CRO sectors for more than 20 years in senior data management and technology roles. He has a long experience delivering EDC and DM projects for clinical trials.
Dennis Wächter	Dennis Wächter is a Technical University Darmstadt qualified informatics specialist of more than 10 years. He has implemented many commercial and scientific projects and has a special interest in systems specification and implementation.
About ADH Solutions
ADH Solutions Ltd	ADH Solutions Ltd is a systems and software house specialising in the provision of products and services for the collection and collation of high quality scientific data, with special emphasis on regulated clinical trials. Their innovative ‘series m500’ EDC tool and design process provides efficient delivery of study data for the pharmaceutical and biotech sectors.