Information Technology (Track 2)

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Information Technology

This track will cover current IT issues affecting the use and validation of applications by regulated companies. The adoption of “Cloud” technology is seen as the biggest current issue facing the life science industry. The focus is therefore on how to educate and encourage users to adopt this technology in a manner that addresses any new risks and meets compliance requirements. The emphasis will be on moving from theory to reality. This session will provide concrete examples and solutions, as well as case studies.

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  • Keith Williams, Chief Executive Officer, GxPi, United Kingdom

Some of the sessions will include: 

Plenary Session: Lifescience Trend and Benchmarking

Life Sciences and Cloud: A Myth or Game Changer

Exploiting Cloud Capabilities for Pharmaceutical Medical Imaging
Omer Casher, Director, IMAQA, United Kingdom

The divestment of the GSK Clinical Imaging Centre into a new entity called Imanova in late 2011 created complex challenges for the IT infrastructure. In particular, GSK hardware and centrally managed regulatory compliant enterprise software had to be replaced and the new solutions had to be commissioned at the time of the transition. Moreover, the Siemens image management system, which had hitherto managed only GSK data, was now required to manage data for external customers. This had implications for data sharing and security for which the data management system was never originally designed.
Cloud computing, which is becoming more widely adopted throughout industry, has played a significant role in this divestment activity. This session will discuss the experiences of implementing Cloud technologies during this period and will highlight the importance of IT standards, such as DICOM, in addressing the validation hurdles.

At the conclusion of this session, participants will be able to:

  • Understand pharmaceutical divestments and the impact on IT
  • Understand Cloud Computing and how it is effectively used in practice 

Qualification and Validation Using IaaS and SaaS
Phil Harisson, Principal Consultant / Product Quality Manager, GxPi, United Kingdom

Many regulated companies are already using infrastructure as a service and software as a service for some of their validated applications. This has meant acknowledging new ways of splitting responsibilities, together with recognising and solving the technical and compliance risks or issues that these new arrangements can involve. Some real examples will be discussed.

From this session, delegates will learn how to ensure information systems can still be implemented and used in a compliant manner, while taking advantage of the benefits of using infrastructure or software as a service.

At the conclusion of this session, participants will be able to:

  • Understand how responsibilities have changed, and the importance of defining responsibilities when multiple service providers may be involved
  • Learn how some old risks have changed, and new risks have emerged as a result of these new arrangements
  • Learn how risks / issues around implementing the use of IaaS and SaaS have been addressed in some recent projects

Clinical in the Cloud
Eric Staib, Director, Global IT Quality, Covance, USA 
Martin Preis, Pharma Quality Expert, PAREXEL, Germany

In order to conduct a clinical trial, a number of key computerised systems are essential. These systems are often hosted and maintained through Cloud and/or SaaS providers. Critical aspects of computerised systems validation and security within the Cloud shall be considered and discussed as part of this session, as well as the current framework of the clinical environment.

Cloud Security for Life Sciences
Jens Jensen, UK Science & Technology Facilities Council, United Kingdom

VMware vCloud Infrastructure and Good Cloud Practice
Dante Orsini, Vice President Business Development, Iland, USA

GMP Considerations for Outsourced Computerised Systems
Stephen Grayson, Medicines Inspector, GMP Inspection Unit, MHRA, United Kingdom

This session will provide an overview of key considerations for enabling a GxP-compliant outsourced computerised system. The presentation will focus on weaknesses observed during inspection which resulted in deficiencies being raised. Delegates will receive guidance on which areas should be carefully considered in respect to the selection, validation and operation of outsourced computerised systems. They will become more aware of common weaknesses in respect to computerised systems observed during inspection.

Plenary Session

  • Track Reviews
  • Compliance Round Table
  • Question and Answer Panel

    Track Leaders and Speakers
    Special Guest Sion Wyn, Director, Conformity Ltd, UK