| Description |
Life Sciences companies today are facing greater challenges in maintaining regulatory compliance while pursuing increased profitability.
Key concerns that need to be addressed include:
• Increased regulatory scrutiny for compliance
• Optimizing costs for drug development and global safety reporting
• Increased distribution controls
Patni Life Sciences’ ADEPT™ (Adverse Event Processing Technology) is one of the leading offerings to provide a cost-effective mechanism to address these challenges.
Patni has:
• Global team of experts in strategic drug safety and pharmacovigilance
• Flexible staffing model allowing rapid response to changing demands
• State-of-the-art compliance knowledge and enabling toolkits
• Visualization solutions combined with detailed risk management planning to allow faster, low risk decision-making
Attend the Patni webinar to get insights on Pharmacovigilance visibility and reporting from Roy Devine, AVP (Drug Safety & Clinical) and Dr. Upender Kapoor, Global Director- Pharmacovigilance Operations. Learn how Patni is helping leading pharma companies remain complaint while reducing costs and improving effeciency.
URL for Registration:
https://patni.webex.com/patni/onstage/g.php?d=689096975&t=a
We sincerely hope you can join us.
Who Should Attend:
• VP-Safety & Compliance, Director, VP-R&D, Pharmacovigilance professionals
• Safety & Medical Directors
• Senior IT executives
Value of attending:
Learn more about trends and strategies in Pharmacovigilance and how Patni ADEPT KPO services can enable:
Support strategic assessments
• Risk Identification and Mitigation activities
• Process Evaluation and Optimization
• Trend Analysis for Proactive Management Decision Guidance
Execute operational business functions
• Collection, Processing, Analysis and Reporting of Adverse Events and Product Compliant Data
• Periodic Regulatory Safety Reporting
• Terminology and Labeling Management
• Routine Regulatory Compliance Auditing, e.g. vendor audits, clinical site audits, IT compliance audits
• Process Evaluation and Optimization
Focus on core research and development, e.g.
• Discovering and developing novel pharmaceuticals and devices
• Quality management right from development to distribution to the patient
Key benefits of ADEPT™
Enhanced Compliance:
• 21 CFR Part 11 compliant systems for Safety and Clinical Data Hosting and Enhanced E2B reporting capabilities
• Validated signaling and visualization systems for Pharmacovigilance and program management
• Client Compliance based SLA delivery model
Efficiency and quality:
• Increased visibility of metrics resulting in increased control
• Reduced cycle time and error rates for Pharmacovigilance activities
• Reporting mechanism to track process metrics and capture process performance
Cost Savings:
• Reduced Cost per Case and reduced regulatory Risk from enhanced reporting
• Reduced IT overhead and maintenance
• Global delivery model
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