Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP Pharma Delivery TCS

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The document discusses several challenges related to pharmacovigilance when the same drug is marketed by different sponsors, such as generic manufacturers. It notes issues around aggregate safety reporting, signal detection, and obtaining safety data from other companies. The document also proposes "Safety in a Capsule" as a software solution that could help address these challenges by providing a unified platform for adverse event reporting, signal detection, and analytics across multiple drug manufacturers.

Santé & Médecine Business Technologie

Challenges in Pharmacovigilance - Different sponsors, same drug Dr. Vishwas Sovani MD , VP Pharma Delivery TCS

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Australian Guidelines for PV responsibilities of sponsors ,[object Object],[object Object],[object Object]

Different Sponsors: Best practices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

PV operations for generic manufacturers ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Finally… Companies can enter into Safety Data Exchange Agreements

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[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Industry Challenges What do we need? Paradigm shift

Ideal safety monitoring system ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Safety in a Capsule ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Unified Architecture for Drug Safety & Pharmacovigilance ADR submitted through Safety Manager ADR collected by the Call Centre Call Centre creates new ADR record which is pulled in by AE Rep System Unified Drug Safety and Pharmacovigilance environment AE Rep System and external DB for Signal detection, assessment & management AE Rep System generated reports for regulatory submission

Benefits Safety in a Capsule ,[object Object],[object Object],[object Object]

Conclusion ,[object Object],[object Object],[object Object],[object Object],[object Object]

Industry Challenges in Pharmacovigilance ,[object Object],[object Object],[object Object],[object Object]

Continuous Safety Monitoring ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Determinants of signal selection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Signal Detection Current Data Mining databases ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Data Mining - statistical techniques ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Safety-in-a-Capsule TM - Solution Stack Services Processes Qualification & Validation Safety & Pharmacovogilance Implementation Configuration Administration Customization Production Support Technology Physical Security Data Security Data Privacy Business Continuity Information Security Monitoring Early warning Threshold triggers E-mail Alerts Signal detection Statistical Analysis Informed judgment Analysis Clinical Review, PA, Comparisons, Correlations, Drug-Drug Interaction Reporting SAE reporting PSUR, SUSAR, Periodic Oracle – AERS Oracle – TMS Oracle – Portal Siebel – Call Center DrugLogic – QSCAN Oracle – Business Intelligence Collection & Processing Maintain Database Data Collection (Call Center, Internet, e-Mail, Fax, etc.) Data Entry Medical coding Cleansing & Scrubbing Validation

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