DIA 2018 Global Annual Meeting

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-537-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Describe the focus of MHRA inspections versus other regulators, such as FDA; Discuss best practices for establishing a fit-for-purpose quality system that meets global PV requirements; Define the core elements for inspection ready; Identify how to utilize the Pharmacovigilance System Master File (PSMF) as an effective inspection readiness tool; List real-world examples of inspection findings and inspection readiness.

Chair

Annette S. Williams

Speaker

Inspection Readiness: How Prepared are Your Systems for Global Regulatory Inspections?
Shelley Gandhi, MS

One Pharmacovigilance System to Satisfy FDA and MHRA’s Inspections
Anil K. Hiteshi, RAC

Inspection Readiness: MHRA Inspectorate Perspective
Joanna Harper