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Monday, June 25 • 3:00pm - 4:15pm
#140: How Inspection-Ready is Your Organization?

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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.


Annette S. Williams


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

avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Joanna Harper

Joanna Harper

Expert Inspector, GPvP, Inspectorate, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA)
Jo joined the MHRA Inspectorate in 2007, having worked for 15 years in the pharma industry. Throughout 2010-2012, she led the inspectors' contribution to the Implementing Regulation and specific statutory guidance GVP Modules in support of the pharmacovigilance legislation changes... Read More →
avatar for Anil Hiteshi

Anil Hiteshi

Vice President, Global Regulatory Affairs, QA, PV and Drug Safety, and CDM, Spectrum Pharmaceuticals, Inc.
I am currently the Vice President of Regulatory Affairs, Quality Assurance and Pharmacovigilance at Spectrum Pharmaceuticals and have over 30 years of experience in the industry. I have previously worked at Anabolic Pharmaceuticals, McGaw Laboratories (now B. Braun), ICN Pharmaceuticals... Read More →
avatar for Annette Williams

Annette Williams

Vice President, Lifecycle Safety, IQVIA
Annette Williams, R.Ph, is Vice President of PV Services at IQVIA, encompassing global Safety Operations (case processing and regulatory reporting), Project Management, and Safety Systems. Williams leads the exploration and adoption of innovative technologies to streamline how Lifecycle... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session