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Katherine Kennedy

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Roche
Katherine Kennedy

Senior PV Quality Director at Roche

  United Kingdom

About me

A Senior PV Quality Director with over 20 years of experience in Pharmacovigilance, I provide strategic leadership and enterprise-level oversight of the Pharmacovigilance System Master File (PSMF) process, with a strong focus on maintaining lean, inspection-ready operating models

Schedule

My Session

Rethinking the PSMF: Smarter Content, Smarter Delivery
  • Traditional PSMF Model: How PSMFs are typically structured and maintained today and why this approach is becoming increasingly difficult to sustain.
  • Inside the Complexity: Unpacking the challenges of remaining inspection-ready.
  • A Smarter Modular Content Approach: Move toward structured, modular content with a clear separation of static and dynamic data to improve consistency, control, and efficiency.
  • Making It Happen: Practical steps for transition, including governance, system, and change management considerations.

Katherine Kennedy

Senior PV Quality Director at Roche

Regulatory Compliance
Quality Assurance
PV Audits & Inspections

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