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DIA 2021 Global Annual Meeting


Assessing Risk in the Pharmacovigilance System for the Purpose of Audit and Inspection

Session Chair(s)

Kiernan  Trevett, MSc

Kiernan Trevett, MSc

  • Expert Pharmacovigilance Inspector
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
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 an innovative approach to pharmacovigilance audit risk assessment and planning utilizing the power of process analysis and statistical modeling; Discuss benefit and limitations.

Speaker(s)

Kiernan  Trevett, MSc

MHRA GPvP Inspections of Additional Risk Management Activities

Kiernan Trevett, MSc

  • Expert Pharmacovigilance Inspector
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Min  Zou

Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning

Min Zou

  • Principal Solution Analyst
  • F. Hoffmann- La Roche, Switzerland
Dipti  Kalra, RPh

Overview of the Risk Evaluation and Mitigation Strategies (REMS) Compliance Program

Dipti Kalra, RPh

  • Team Leader, Office of Scientific Investigations, OC, CDER
  • FDA, United States
Danielle  Pearson, BSN

Overview of the Risk Evaluation and Mitigation Strategies (REMS) Compliance Program

Danielle Pearson, BSN

  • Consumer Safety Officer, OSI, CDER
  • FDA, United States