Register

The g Hotel, Galway

Maryborough House Hotel, Cork

Agenda

About the Speakers

David Stokes - Business & Decision
David Stokes is Global Head of Life Sciences for Business & Decision, where he provides strategic consulting to a variety of pharmaceutical, medical device and biotechnology companies. Before joining Business & Decision (formerly Mi Services Group) he spent fifteen years in the field of process control and automation and was closely involved in the implementation and validation of manufacturing solutions in the life sciences industry. Since joining Business & Decision in 1999 he has become involved with large, complex R&D, supply chain and manufacturing projects, providing guidance on risk management, computer systems validation and regulatory compliance to a number of organisations such as: Sanofi-Aventis, GlaxoSmithKline, AstraZeneca, Novartis, St Judes Medical, the American Red Cross and GE Healthcare.

Dr. Malcolm Moore - SAS
Dr. Malcolm Moore has worked with clients to integrate statistical methods and software into R&D, quality improvement, defect reduction, cycle time reduction, and corporate Six Sigma consulting activities for a variety of industries, including pharmaceutical and semiconductors. Prior to joining SAS UK he worked at Light Pharma, BBN, Astra Zeneca and lectured in Medical Statistics at Newcastle University. He is an expert in design of experiments, and received his Ph.D. in Design of Non-Linear Experiments at London University.

David McMahon - SAS
David McMahon is Client Director at SAS Ireland. He has over 14 years experience in the technology sector. David was General Manager of Labyrinth; a Dublin based Internet Solutions Company, where he was instrumental in taking the company to a market dominant position. On BTs acquisition of Labyrinth, David was responsible for managing web solutions businesses based in Ireland, the UK and the Netherlands. He has also held senior positions in Vodafone and AHC Systems Consulting. David has a Business Degree from Trinity College and a Masters in Science from the London School of Economics.

Objective
Business & Decision organises a regular series of industry workshops in order to:

• Allow the Life Sciences user community to identify common issues in the overlapping areas of business efficiency, regulatory/IT compliance and computer systems validation.
• To provide a forum to discuss these issues.
• To identify and share pragmatic, industry best practice solutions.
• This specific workshop is intended to look at The Role of Data Quality in Regulatory Compliance. The workshop will focus on the Biostatistical techniques in Research and Development, the use of data standards in Clinical Trials and data analysis in the development of PAT (Process Analytical Technology) models.

Workshop Format
Unlike other seminars or meetings, where the majority of time is spent listening to ‘talking heads’, the workshop format is designed to allow maximum interaction between attendees. Facilitated by experienced consultants from Business & Decision and invited industry experts, each session will provide an update on current IS technology and is designed to outline specific issues and to discuss them in an interactive forum. Attendees are invited to prepare for the workshop by considering the relevant issues within their own organisation and how some of these problems are being tackled. Because the objective of the workshop is to facilitate an open discussion of problems and solutions, all information exchanged is treated on a confidential basis and all attendees are expected to respect this principle.

Who Should Attend?
This workshop is intended for those responsible for:Implementing a service oriented IS model,

• The provision of service oriented information systems,
• The validation / qualification or regulatory oversight of IS services,
• The project management of associated projects.

Typically this will include senior management and system owners, quality managers, staff responsible for computer systems validation, CIOs/IT managers and project managers

What Does It Cost?
Attendance at this event is free of charge. Refreshments and a buffet lunch are provided. Attendees are expected to pay their own travel and accommodation costs.

How Many Places Can I Book?
Attendance from a cross section across the organisation is most beneficial at such a workshop. However, the workshop format works best with representatives from different organisations. Places are limited and are generally allocated on a first come, first served basis and early registration is advised. The organisers may request companies to restrict numbers from their organisation in order to ensure a representative sample from the industry.

How Do I Reserve Places at the Workshop?
Please complete the booking form below. If you wish to register multiple people from your company please enter their names and contact information in the "Additional Attendees" section. If these people are based at a different address than the one you intend to enter in the "About You" section, we would be grateful if you completed a separate registration form for these people so that we have a record of this additional address.