概要

This virtual live training course will teach concepts, access policy, and use of the EudraVigilance Data Analysis System (EVDAS) for signal detection. Experienced trainers using EVDAS on a regular basis will share practical advice on how to download and interpret the data and use it for signal detection.

The EudraVigilance data analysis system (EVDAS) supports EU pharmacovigilance safety monitoring activities with the focus on signal detection and evaluation of ICSRs. Marketing authorisation holders with active substances included in the list published by the European Medicines Agency have to monitor and inform authorities of validated signals with their medicines. GVP Module VII "Periodic Safety Update Reports" states that also for other active substances, MAHs are expected to include data from EudraVigilance whenever there are signal evaluations in the PSUR triggered by other sources of information.

The course is based on the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management, Commission Implementing Regulation (EU) No. 520/2012. Time has been set aside for practical exercises, questions, and discussions.

特集トピック

GVP IX and Addendum I
Screening for adverse reactions in EudraVigilance (EV)
Principles of access in EV
Practical use of EVDAS and exercises:

eRMR analysis and documentation
Line listing analysis
CMDh list of safety concerns
Referrals page on the EMA website
List of signals discussed by the PRAC since 2012
How to escalate signals, e.g. stand-alone notification, ESI

参加対象

This virtual live training course is aimed at professionals who work in:

Pharmacovigilance (including QPPVs)
Drug Safety and Patient Safety Risk Management
Information Technology
Pharmacovigilance Data Management
Pharmacovigilance Consultancies
Quality and Compliance

Course level: Intermediate, for professionals with 2-3 years of experience in Pharmacovigilance who work in the area of signal management but have no or limited experience on how to use EVDAS for signal detection.

学習目的

At the conclusion of this virtual live training course, participants will be able to:

Identify regulatory requirements for Signal Management in Europe (GVP IX and Addendum I)
Describe principles of screening EudraVigilance for adverse reactions and the EudraVigilance data access policy
Identify levels and methods of access to Individual Case Safety Reports (ICSRs) data and understand the terminology of EVDAS
Discuss the use of active substance grouping reports, and electronic reaction monitoring reports (eRMRs)
Analyse eRMRs with various reference periods and line listings and document your assessments
Identify potential signals and know how to escalate them to the National Competent Authorities (NCAs) and the European Medicines Agency (EMA)

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EudraVigilance Data Analysis System (EVDAS): Practical Approach on Use for Signal Management in the EU