DIA 2016 Annual Meeting

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

On July 1, 2015, the European Medicines Agency initiated the monitoring of medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances and entering the relevant information into the EudraVigilance database. One of the key objectives of this initiative is to prevent duplication of cases reported by multiple marketing authorization holders (MAHs) for the same active substance through worldwide literature searches. Other intended benefits are to enhance the efficiency of adverse reactions reporting, improve data quality, contribute to resource savings, simplify processes, and support signal detection activities. This session will discuss the need for MAHs to assess the impact of this initiative on their existing process of literature safety report identification, case processing, and expedited reporting.

Learning Objectives

Identify the salient features of the European Medicine Agency's (EMA) medical literature monitoring (MLM) service; Assess the impact on existing global literature search, case processing, and expedited reporting; Identify measures required to align existing pharmacovigilance processes consequent to the implementation of EMA’s MLM service.

Chair

Vineet Kacker, PhD

Speaker

EMA Medical Literature Monitoring Service: Impact on EU Pharmacovigilance
Vineet Kacker, PhD

Authority-Based Medical Literature Monitoring in the EU: Impact on US and Global Pharmacovigilance
Leonardo Ebeling