EudraVigilance and EVMPD

OBJECTIVES

This course aims to give you a knowledge and understanding of EMA’s EudraVigilance.

Specific highlights:

EudraVigilance nature, purpose and features
Eudravigilance reporting modules (post-authorisation and clinical trials)
Recent changes to Eudravigilance pharmacovigilance system (XML formats and impacts to safety database set-ups, Access policy considerations, Signal detection requirements, Medical Literature Monitoring)
Electronic ICSR preparation
Medical product information
What is the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and what does it provide
Importance of XEVMPD data in the revised Eudravigilance system
Applied rules and methods to populate the dictionary : electronic reporting through the ESTRI gateway

Eudravigilance, EMA, pharmacovigilance system, EU pharmacovigilance, EU regulations, SUSAR, safety database, adverse reactions, ADR, ICSR, MAH, reporting, post-authorisation, clinical trials, xEVMPD, EVMPD, Article 57, Signal detection, ESTRI

LEARNING OUTCOMES

At the end of this course, you will be able to:

know what EudraVigilance is, the purpose of it and what it supports

know to the reporting modules that EudraVigilance provides

know changes to Eudravigilance
- XML formats and impacts to safety database set-ups
- Access policy considerations
- Signal detection requirements
- Medical Literature Monitoring