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
Inspection Readiness: How Prepared are Your Systems for Global Regulatory Inspections?
Shelley Gandhi, MS
NDA Group, United Kingdom
Understanding the Focus of FDA Versus MHRA Pharmacovigilance Inspections Based on Our Experience from a Small Company Perspective
Anil K. Hiteshi, RAC
Vice President, Global Regulatory Affairs, QA, PV and Drug Safety, and CDM
Spectrum Pharmaceuticals, Inc., United States
Expert Inspector, GPvP
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom