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Work Package 5 – Signal Management

This Work Package sought to develop and improve understanding of best practice in signal management within the network of National Competent Authorities (NCAs). Questionnaires were used to gather information on capabilities for all aspects of signal management including signal detection, signal validation, signal assessment, and signal management of reports of special interest. It also built on work done to improve signal detection from medication error and misuse/abuse of medicines. Using this intelligence, best practice guide and e-learning module were created and shared with the European Network through training sessions.

Click here to access WP5 learning materials. 

Objectives

Implementing shared understanding of best practice in signal management across the EU network

Topics

Within Work Package 5, there were four individual topics which partners were working on:

  1. Signal detection– lead: MEB
  2. Signal validation/prioritisation – lead: AEMPS
  3. Signal assessment – lead: DKMA
  4. Reports of special interest – lead: MHRA

SCOPE Survey Report and deliverables

European Member States were asked to complete a Work Package 5 survey in order to identify their current methods and preferences in place for signal management. The survey results explored the heterogeneity in the methods used for signal management across Europe. Responses were collated and analysed, and were used to construct guidance deliverables for SCOPE Work Package 5.

SCOPE WP5 Survey Report 2015

WP5 identified publications addressing various scientific aspects of signal management with potential useful tools and ideas relevant in the European regulatory setting. 

SCOPE WP5 Literature Review on Signal Management

The Best Practice Guide (BPG) provides recommendations and advice on the practical aspects and challenges of signal management for NCAs, with focus on signal detection, validation, reports of special interests and signal assessment. The target audience is primarily European assessors and signal management staff working at European NCAs involved in any step of signal management process. However it may also be useful for other stakeholders involved in signal management. WP5 has also delivered an e-learning module focusing on all aspects of signal management.

SCOPE WP5 Signal Management Best Practice Guide

Introduction to Signal Management E-learning Module

Signal management training

The training session was delivered on 5th October 2016 in Budapest and focused on the signal management processes within the national network. Topics covered included practical advice on signal detection, validation, reports of special interests and signal assessment.

Partners involved

Lead: MEB (Netherlands)

MPA (Sweden)

AEMPS (Spain)

DKMA (Denmark)

MHRA (UK)

Work Package 5 aims to develop an improved understanding of best practice in signal management
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