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ONLINE TRAINING: The Use of EudraVigilance Data Analysis System (EVDAS) in the Signal Management System
- Using EVDAS in signal management systems for signal detection and signal evaluation
- EudraVigilance access policy and recent updates of the EudraVigilance system
- Introduction of EVDAS and its 3 report types
- Strategy to analyse eRMRs and line listings retrieved from EVDAS
- the use of EVDAS to evaluate (validated) signals identified via other sources than EVDAS (i.e. literature search, database, ICSRs, etc.)
- the use of EVDAS for signal detection
- the implementation of EVDAS data in PSURs
- Different strategies to analyse the information retrieved via EVDAS
- How to identify potential risks via EVDAS – tips to define your parameters to select relevant information.
- How to analyse a line listing, what it is needed to be taken into account and few tips to make the analysis smooth.
Harmonie completed her studies in biochemistry, molecular & cell biology and molecular physiopathology. She joined the medical science and PV department of Dr. Ebeling & Assoc. GmbH – an experienced pharma consultancy in January 2019. Early on, she got involved in the development of the EV-based Signal Management (EViSiMa®) project and became the project leader. Her goal is to continuously improve the system to ensure compliance with EMA´s requests by proposing an efficient/optimized approach to detect, validate and further assess signals via EVDAS. Prior to this, Harmonie did 3 years of research in academics before following a training in Clinical Research. She then worked in a biotech company in both Clinical Operation and PV Departments.
Wednesday, June 17, 2020
At the end of the training, you will be able to
The audience will be able to define the new responsibilities associated with the EudraVigilance Data Analysis System (EVDAS)
The participants will be qualified to differentiate significant information from the complex datasets provided by EVDAS and find pragmatic solutions for the monitoring of the new system