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Case Study: Successful Implementation of End-To-End Pharmacovigilance Services For Drug-Device Combination Product Portfolio

the situation

The Situation

  • EVERSANA was approached to provide pharmacovigilance services to a small-sized pharma company with generic products and a portfolio in the U.S. and Europe (5 products with 2 combination products).
  • The client needed a service provider who understands the granularity of complex regulatory requirements for their combination products and delivers end-to-end PV services.
the solution

The Solution

  • Implementation of End-to-end PV Services: A Safety Management Plan was developed outlining the roles and responsibilities to cover the post marketing reporting of the individual cases and aggregate reports. We provided ICSR, Literature and Aggregate services.
  • Combination Product Configuration in the Safety Database: Client was onboarded into safety database with all detailed configurations that are required for submission as per Regulatory requirements.
  • Strategic Advice on Quality Management System: Strategic advice to the client, review of their internal SOPs and procedures to ensure regulatory compliance to combination requirements.
  • Aggregate Reports: EVERSANA also developed a customized PADER template for these products to accommodate the sections specific for the device reports for these products.
the results

The Results

  • Established PV system catering to all combination products for ICSR and aggregate reports.
  • The client continues to work with EVERSANA and has been extremely satisfied with the services.
  • The client has been 100% compliant with regulatory requirements and has initiated discussion about their other portfolio for services.