Patni’s Life Sciences Practice provides thought leadership and expertise to life science companies in the areas of compliance, enterprise, LIMS & Lab Informatics, and Drug Safety & Pharmacovigilance to help address their unique business and information technology needs. Please contact us at lifesciences@patni.com to find out more about any of our upcoming speaking engagements.
Speaking Engagement: DIA 2008 Annual Meeting
June 22-25, 2008, Boston, MA
Speakers: Steve Jolley, Vice-President & Head of Pharmacovigilance at Patni Life Sciences; Carol Krueger, Surveillance Programs Team, FDA
Schedule: Sunday, June 22, 2008, 8:30 a.m. to 12:00 p.m.
Tutorial: Pharmacovigilance Assessment and Risk Management: Essential Components to Good Pharmacovigilance Practice
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How to demonstrate a commitment to Good Pharmacovigilance to optimize drug development and commercialization |
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Review of the pharmacovigilance assessment profile which captures the requirements of all applicable regulatory bodies, reviews company practices across the product lifecycle, inspects detailed documentation on case processing and decisions made, evaluates related information systems, and documents successes, failures and improvements. |
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How to assess the need for formal risk management plans (RMPs) |
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The importance of collecting risk information generated during clinical trials and long-term controlled safety studies |
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Signaling programs and pharmacoepidemiologic assessments to further identify and analyze potential populations at risk. |
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At the conclusion of this tutorial, participants should be able to: |
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Discuss the importance of a pharmacovigilance assessment and risk management plans in ensuring Good Pharmacovigilance Practice |
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| Contact us: For more information, call Melissa Michels at (908) 255-1606. |
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Speaking Engagement: LabWare Conference 2008
April 27-May 2, 2008, Santa Ana Pueblo, New Mexico
Speakers: Vibha Chawla, Sr. Specialist, LIMS & Lab Informatics for Patni, John Millard for SANDOZ
Schedule: Wednesday, April 30, 2008, 1:30 p.m.
Session: Stability Implementation: Pharma Template Enhancements |
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The LabWare LIMS Pharma Template solution provides a good starting point for meeting complex pharmaceutical laboratory requirements while helping reduce the cost and effort of implementation. However, implementing this solution can be challenging if installed on top of an existing LabWare LIMS configuration. |
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Configuration updates required to stay consistent with existing processes and in order to bridge any gaps between the Pharma Template and client requirements. |
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General overview of the solution, the challenges encountered and some key success factors for such an implementation through description of an actual case study. |
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Contact us: For more information, call Melissa Michels at (908) 255-1606. |
