Operations Intelligence-PVTM
Operations Intelligence-PVTM is the first step to obtain a firm understanding of where your safety department stands with regard to current pharmacovigilance requirements.
Operations Intelligence-PV measures your key drug safety components against industry best practices as shown in the diagram below:
Assessment
Operations Intelligence-PV incorporates a comprehensive set of diagnostic questions to assess each of the critical components of pharmacovigilance. It includes best practices and a cross-reference to applicable laws, regulations, and guidelines in the United States, Europe, and Japan. This assessment includes an analysis of:
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Pharmacovigilance strategy |
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Adequacy of quality control and assurance |
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Case handling processes |
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Signal detection capabilities |
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Risk management planning |
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Safety-related systems |
Education
In conjunction with Operations Intelligence-PV, Patni offers customized training on the principles of pharmacovigilance and on specific regulations pertaining to the findings.
Gap Analysis
Operations Intelligence-PV provides a detailed analysis that defines and prioritizes each gap in your current organization and links each gap to a specific law, regulation, guidance or best practice. Operations Intelligence-PV also provides detailed recommendations on how to close or mitigate each gap identified during the diagnostic phase.
How Patni Can Help
Patni's comprehensive set of drug safety products and services, Intelligent Solutions-PVTM, can help you improve processes, procedures, signaling capabilities, documentation and proactive monitoring. Compliance with Good Pharmacovigilance Practices is essential for a company to demonstrate it has followed the appropriate procedures during development and post-marketing in order to protect patient safety. Patni remains committed to helping our clients bring new products to market and to protect our clients' existing products.
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