The Underpinnings of Good Informatics Practices
Presentations | White Papers & Case Studies
Presentations
| 7:30 — 8:00am | Registration and Breakfast | |
| 8:00 — 8:15am | Opening Remarks LSIT and GIP - Learn more about our mission and the value of GIP. Presenter: Elaine Wuertz, Chairman, LSIT Global Institute Board of Directors & Program Manager, Innovation and Informatics, Office of the CSO, Accelrys | |
| 8:15 — 8:45am |  Presenter: Michael Hehenberger, Ph.D., Solutions Executive, Life Sciences R&D, IBM Healthcare & Life Sciences | Download Presentation |
| 8:45 — 9:15am |  Addressing the very complex hospital system models and establishing business value in key processes with many stakeholders. Comparing the complexities in healthcare with applicability to life sciences. Presenter: Steven Barnard, Life Sciences Marketing, Intel Corporation | Download Presentation |
| 9:15 — 9:45am | Presentation: GIP and Risk Management The relationship between GIP and the risk based approach (RBA). What are some strategic decisions in risk management? Presenter: Elaine Wuertz, Chairman, LSIT Global Institute Board of Directors & Program Manager, Innovation and Informatics, Office of the CSO, Accelrys | Download Presentation |
| 9:45 — 10:00am | Coffee Break, networking, check emails | |
| 10:00 — 10:30am | Presentation: Using the Risk Based Approach A case study of Good Informatics Practices (GIP) for Risk Management applicability in the Security Chapter Presenter: Steven Fouskarinis, LSIT Board of Directors, Security Chapter Working Group | Download Presentation Handout 1 Handout 2 Handout 3 |
| 10:30 — 11:00am |  One of the largest uses of budget and resources in IT lies in the challenge of integrating, aligning, and harmonizing data across the company. Where is your data? How do you get it? Can you trust it? How do you control it? This session will help you learn how to better understand your data, while governing its quality to provide authoritative information. Presenter: Jackie Golden, Dataskill, Sr. Vice President MDM Services | Download Presentation |
| 11:00 — 11:30am |  Think out of the box with a SaaS Model of IT Infrastructure and Application Delivery for optimum Security Presenter: Bob Cohen, Global Life Sciences, Sr. Vice President | Download Presentation |
| 11:30 — 12:00pm | Lunch and Presentation: IT functionality moving to services. An audience discussion on the IT services, and the optimal management of these services with respect to managing risks. Who owns the risks? Who will regulatory bodies hold responsible ? How do you ensure Trust in your IT systems? Conquering compliance with Quality, Validation and Trust. Presenter: Elaine Wuertz, Chairman, LSIT Global Institute Board of Directors & Program Manager, Innovation and Informatics, Office of the CSO, Accelrys | Download Presentation |
| 12:00 — 12:30pm |  An overview on process development and planning for good Validation. Planning the work and working the plan on Validation mapping, Quality systems and vendor selection. Discussing the challenges of Quality Implementation and system validation. Presenter: Tony Stolis, Clarkston Consulting, Management and Strategy | Download Presentation |
| 12:30 — 1:00pm |  Learn how Qualcomm is address integration challenges, validation and security for their vendors. Presenter: Don Jones, Qualcomm, VP Healthcare and Life Sciences | Download Presentation |
| 1:00 — 1:20pm | Breakout Sessions (simultaneous) We are Listening — audience dialogues on perspectives, issues and ideas in:
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| 1:25 — 1:40pm | Wrap Up Summary of the Breakout Sessions Lessons learned and ideas for moving forward - Presenter: Paul Laskin, LSIT, Technology Advisory Board | |
| 1:40pm | Seminar Adjourned |
White Papers & Case Studies
- IT Solutions for imaging biomarkers in biopharmaceutical research and development (IBM)
- Case Study: Healing Environment, Proven Value (Intel)
- Transforming Regulatory Compliance from a Burden to a Competitive Advantage (Dataskill)
- The Value of Healthcare IT: A Practical Approach to Discussing and Measuring the Benefits of HIT Investments (IBM)
- Guidance for Industry Computerized Systems Used in Clinical Investigations
- ICH: Guidance for Industry: Q9 Quality Risk Management
- PRESS RELEASE: Biopharmaceutical infrastructure key to lower drug development costs