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Wednesday, June 30 • 2:00pm - 3:00pm
#340 SL: Assessing Risk in the Pharmacovigilance System for the Purpose of Audit and Inspection

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-620-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Kiernan Trevett, MSc


MHRA GPvP Inspections of Additional Risk Management Activities
Kiernan Trevett, MSc

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

Overview of the Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
Dipti Kalra, RPh

Overview of the Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
Danielle Pearson, BSN

avatar for Kiernan Trevett

Kiernan Trevett

Expert Pharmacovigilance Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012 and is currently working in the role of Expert GPvP Inspector. She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP), has had... Read More →
avatar for Min Zou

Min Zou

Principal Solution Analyst, F. Hoffmann- La Roche, Switzerland
Ms. Min Zou is currently the principle quality solution analyst at Roche. She worked in the Pharmaceutical industry for over 10 years, both in China and Europe. She is an expert in Business Analysis, Process Excellence and leading Advanced Analytics projects in the areas of Commercial... Read More →
avatar for Dipti Kalra

Dipti Kalra

Team Leader, Office of Scientific Investigations, OC, CDER, FDA, United States
CDR Dipti Kalra is a Team Leader of the Risk Evaluation and Mitigation Strategies (REMS) Compliance team in the Office of Scientific Investigations, Office of Compliance at the Food and Drug Administration (FDA). She is a commander with the United States Public Health Service. She... Read More →
avatar for Danielle Pearson

Danielle Pearson

Consumer Safety Officer, OSI, CDER, FDA, United States
Danielle Pearson is a Consumer Safety Officer in the Office of Scientific Investigations, Office of Compliance on the Risk Evaluation Mitigation Strategies (REMS) Compliance Team. She graduated from Howard University with a Bachelor of Science in Nursing. She is responsible for selecting... Read More →

Wednesday June 30, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session |   01: ClinSafety-PV, Session