The Programme

Programme Day One Tuesday 25th November 2008
08.30		Registration
09.00	Chaired by: Henrik Nakskov Head of Knowledge Management and Competency Development Novo Nordisk	Opening remarks from the Chair
The continuing evolution of Electronic Data Capture (EDC)
09.10	Mette Mackeprang Bruhn EDC Team Leader H. Lundbeck	The current EDC landscape Revolutionising the way we conduct clinical trials Questioning whether EDC has affected the quality of data and information collected in clinical trials Assessing the major trends in the evolution of systems Suggesting why the introduction of EDC still remains a challenge and explaining how this challenge has changed over the years Where do we want to be in five years from now and what will be the hottest topic of debate?
09.40	Martin Semrau Enterprise Architect Novartis Pharma	Effective communication across departments Rethinking the way different departments handle and manage data Improving inter-organisational communication and collaboration Expanding data management knowledge using the IT structures involved
Knowledge management: from theory to practice
10.10	Prof Ron Summers Professor of Information Science University of Loughborough	Knowledge management in clinical trials Defining knowledge management challenges in the context of clinical trials Providing technical and business objectives for a web based clinical trials support system (CTSS) Adopting Web 2.0 semantic technology and using XML as the basis for an interoperability framework
10.40		Morning refreshments
11.10	Henrik Nakskov Head of Knowledge Management and Competency Development Novo Nordisk	Incorporating Supply Chain Management (SCM) and Service Orientated Architecture (SOA) to optimise clinical trials and knowledge management Compensating for the exponential growth of data and its disruptive effect upon trial operations Optimising data management through process focus and knowledge leadership Building up the decision foundation
11.40	Jerry Lanfear Head of Data Support and Management Pfizer	Data capture and management: a perspective from early research Evaluating the challenges for data capture and management in the earliest phases of drug discovery Assessing the technical, organisational and cultural approaches Pfizer have undertaken to tackle these challenges Discussing what remains to be done
Using EDC to enhance business processes
12.10	Brian Raftery General Manager Dr. Oestreich & Partner	EDC and query management Experiences with the handling of human and system created queries and their lifecycles Using the EDC environment to optimise the query resolution process in real-time Query metadata: how to improve the quality of data flow and reduce query creation
12.40		Lunch
14.00	Jason Housley Senior Clinical Data Manager Shire	Really adding business value Examining the inefficiencies in our traditional EDC and paper processes Showing where the machine executable meta-data is the driver to auto –configuration of systems Conducting a brief benefits analysis Hypothesising on the future state in both insourced and outsourced solutions
14.30	Richard Young Director of Business Development CMED Ltd.	EDC: the new clinical trials landscape eSource Adaptive trials Geographical locations The iPhone Revolution
Offshoring and outsourcing data management
15.00	Susan Gales Associate Director Global Development Data Operations Wyeth	The Wyeth and Accenture data management alliance - 5 years achieved Expectations of the alliance and progress to date Determining what lessons have been learnt Unlocking the secrets of a successful relationship How has and how will the alliance evolve?
15.30		Afternoon refreshments
16.00	Dr. Johann Pröve Global Head Data Management Bayer Schering Pharma	Offshoring and Outsourcing: analysing the direct effect on data managers Assessing the changing function of the data manager and organisation Preparing data managers for the future Ways of increasing and improving with in-house data management
Solving data management issues
16:30	Kjell Pennert Director of Data Management Richmond Pharmacology Ltd	Challenges in Phase I Data Management (DM) and beyond Phase I and current model Transition to standalone DM Phase II-IV Challenges and solutions
17.00	Alison Macdonald Director Digital Archiving Consultancy Limited	Digital archiving: making it easier Awkward issues along the way: human, organisational, technical, legal and more Tools and technologies The benefits to be earned Digital archiving, data management and corporate strategy
17.30		Closing remarks from the Chair and close of Day One

Programme Day Two Wednesday 26th November 2008

08.30

Registration

09.00

Chaired by:
Mette Mackeprang Bruhn
EDC Team Leader
h. Lundbeck

Opening remarks from the Chair

09.10

Roundtable morning sessions

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of data management


1	Exploring the possibility of EDC becoming obsolete Bengt G Fältström Senior data management analyst ASTRAZENECA	2	Electronic Health Records (EHR): why would patients ever trust pharma with them? Dr. Mats Sundgren Principal Scientist Astrazeneca	3	Overcoming internal politics: creating an organisational structure to increase efficiency Jerry Lanfear Head of Data Support and Management Pfizer

4	Reducing the slow uptake of EDC Mette Mackeprang Bruhn EDC Team Leader h. Lundbeck	5	Archiving difficult data: what are difficult data and how do we deal with them from an archival perspective? Alison Macdonald and Philip Lord Directors Digital Archiving Consultancy Limited	6	How pharma manufacturers are coping with the increasing number of standards Simon Bishop Director and Head of Data Standards GlaxoSmithKline

12.30		Lunch
Standardising the global system
13.40	Udo Siegmann Member of the European CDISC Co-ordination Committee	The future of standardisation Developments in CDISC: initiatives with other standards organisations and moving forward in public healthcare Implementing CDISC standards into the data process CDASH: highlighting the progress of the initiative
14.10	Dave Iberson-Hurst VP of Technical Strategy CDISC	CDISC: towards fully integrated standards The CDISC technical roadmap for 2009 and 2010 Detailing how CDISC is ensuring the integration of its standards Describing the development in the CDISC HL7 project for FDA data submission standards
14.40	Simon Bishop Director and Head of Data Standards GlaxoSmithKline	Practical experience of applying CDISC standards within Clinical Data Management (CDM) processes Introducing CDISC’s CDASH, SDTM and terminology standards Practical examples of how GSK has applied these Outlining how implementation of CDISC standards impacts CDM
15.10		Afternoon refreshments
Data management from an investigator’s perspective
15.40	Dr. Fraser Inglis Consultant Physician Glasgow Memory Clinic	Data management at the investigational site Examining the traditional role of the investigational site The assimilation of the study data Considering the challenges and opportunities of EDC The changing role of the research team
Improving industry safety
16.10	Dr. Mats Sundgren Principal Scientist Astrazeneca	The opportunities and challenges of utilising Electronic Health Records (EHR) Reviewing the trends, definitions and penetration of EHR The legal aspects and EU issues Outlining EFPIA’s three pilot projects as the basis for concrete recommendations (core data sets, third party assessment, standard service for patient recruitment) The way forward: status of EU initiatives and discussion about the opportunities
16.40	Dr. Jos Devlies Medical Director Eurorec	Pharmacovigilance as an example of secondary use of EHR data The general principles on secondary use of EHR data Discussing the possible roles of the EHR in adverse event documentation, confirmation and detection Do EHR systems fit for these roles? The Importance of the way an EHR system is used. Evaluating whether we need more than a good system and a perfect user
17.10		Closing remarks from the Chair and close of conference