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Assessing Risk in the Pharmacovigilance System for the Purpose of Audit and Inspection
Session Chair(s)
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
Medicines regulatory agencies and marketing authorisation holders each have a responsibility to supervise pharmacovigilance systems to ensure that the overall quality objectives of a pharmacovigilance system are met. These objectives include ensuring that legal pharmacovigilance requirements are complied with and that patients and public health are protected. One means of achieving this supervision is via inspections and audits, and risk-based principles are applied to help ensure that the highest risk elements of the system are subject to this type of supervisory activity. This session explores some of these principles from the perspective of two regulatory agencies and an industry representative.
Learning Objective : Describe examples of risk-based principles to aid the selection of pharmacovigilance tasks and responsibilities for audit and inspection; Identify different approaches to inspections of risk management systems; Outline some of the issues identified during inspections of risk management systems.
Speaker(s)
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
MHRA GPvP Inspections of Additional Risk Management Activities
Min Zou
Principal Solution Analyst, F. Hoffmann- La Roche, Switzerland
Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning
Dipti Kalra, MBA, MS, RPH
Team Leader, Office of Scientific Investigations, OC, CDER, FDA, United States
Overview of the Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
Danielle Pearson, BSN
Consumer Safety Officer, OSI, CDER, FDA, United States
Overview of the Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
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