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Regulatory Success in a Cloud Environment (2A)

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Monday, 4 June 2012, 14.00 – 15.30

Moderator: Randy Perez, Director, Information Governance and Management, Novartis, USA
Co-Moderator: Bob Tollefsen, Consumer Safety Office, FDA, USA

Life science companies have outsourced many aspects of their manufacturing and research processes for years. The outsourcing trend has also hit the IT world in the past decade. Most recently a combination of cost factors and technological progress has made “cloudsourcing” an economically enticing option. The life science industry has long believed that they had different requirements for information management than other industries. But is that true?

This session will examine some potential pros and cons for maintaining regulated data in the cloud, and will address the information security triad that defines the requirements for a cloud solution: how can you assure adequate confidentiality, availability, and integrity of data.

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

  • Understand the advantages and disadvantages of embracing a cloud solution
  • Learn how other industries have addressed many of the same issues that face life science companies
  • Learn how the right cloud provider can provide equivalent, and in some cases better, protection for your data than you could in your own data center
  • Understand how a cloud solution can in many ways be equated to outsourcing your data center

Session Agenda 

14.00 – 15.30
Regulatory Success in a Cloud Environment
Session Moderator:
Randy Perez, Director, Information Governance and Management, Novartis
Co-Moderator: Bob Tollefsen, Consumer Safety Officer, FDA

14.00 – 14.30
Demystifying the Cloud
Chris Hines, Partner, IBM Global Business Services, Life Sciences Application Innovation Services Leader

14.30 – 15.00
Keys to Cloud Computing: Confidentiality, Availability, and Integrity
Chad Skipper, Chief Security Officer, NetForensics

15.00 – 15.30
Q & A Panel
Chad Skipper, NetForensics, Chris Hines, IBM and Bob Tollefsen, FDA

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