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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


How Inspection-Ready is Your Organization?

    Session Chair(s)
      Annette S. Williams, MBA, RPh

      Annette S. Williams, MBA, RPh

      • Vice President, Lifecycle Safety
      • IQVIA, United States
    This session will provide an overview of the current state of regulatory inspections – what is their current focus, as well as how inspections align and can vary between regulatory agencies. The MHRA will present a summary on the most common inspection findings as well as guidance on how best to address. Core elements of a comprehensive pharmacovigilance system will be reviewed to detail how one’s organization can achieve and maintain an “Inspection-ready” state. The Pharmacovigilance System Master File (PSMF) is a foundational element that can be invaluable in achieving this goal as it can support the safety governance model to reassure stakeholders the company’s ability to protect patient safety while meeting both global and regional requirements. A detailed review of the key PSMF components and their ability to align with inspectors’ requests will be discussed. Additionally, the session will feature real-world examples of how organizations are able to demonstrate their inspection readiness.
    Learning Objective : Learn how to utilise the PSMF as an effective inspection readiness tool Understand better the regulatory requirements for the PSMF including best practices to update and maintain it including how to ensure quality of its data. Discover the rationale for using the PSMF as a tool for PV training. Examine the practical relationships and interfaces between the safety and different functions globally
    Speaker(s)
      Shelley  Gandhi, MS

      Inspection Readiness: How Prepared are Your Systems for Global Regulatory Inspections?

      Shelley Gandhi, MS

      • Strategic Advisor
      • NDA Group, United Kingdom
      Anil K. Hiteshi, RAC

      One Pharmacovigilance System to Satisfy FDA and MHRA’s Inspections

      Anil K. Hiteshi, RAC

      • Vice President, Global Regulatory Affairs, QA, PV and Drug Safety, and CDM
      • Spectrum Pharmaceuticals, Inc., United States
      Joanna  Harper

      MHRA Perspective

      Joanna Harper

      • Expert Inspector, GPvP
      • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom