DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-644-L04-P; CME 1.00; RN 1.00

This session will outline the risk assessment approaches undertaken by four global regulators, the US FDA, UK MHRA and EMA to identify suitable candidates for inspection and explain the differences in inspection cycles. The session will focus on the risk assessment methodologies undertaken by each regulator, highlighting information sources, risk assessment processes and decision-making factors which help determine define the appropriate type of inspection and frequencies. The session will provide information into the types of inspection which may be undertaken for pharmacovigilance and why a company may be subject to one of these inspection types as well as explain why the same company may be subject to more frequent inspections. The session will include information on new and existing initiatives between regulators to collaborate on inspection risk assessments to share information, improve process, and reduce the inspection burden on industry. Companies can use the information from this session to gain tips to help identify and assess high-risk areas of their own pharmacovigilance systems for quality processes such as auditing.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Chair

Sophie Radicke, MSc

Speaker

EMA Perspective
Peter Twomey, MA, MPharm

US FDA Perspective
Sheilyn Huang, PharmD