Introduzione
The EudraVigilance Data Analysis System (EVDAS) launched in 2018 represents a new and very important source for signal detection and signal evaluation in Europe by providing Marketing Authorisation Holders (MAH) access to one of the biggest pharmacovigilance database in the world. According to the Guidelines on Good Pharmacovigilance Practices (GVP) and other regulatory documents, EMA demands the obligatory use of this system for the evaluation of signals detected via other sources than EVDAS (so called external signals) and partly also for signal detection. Furthermore, EVDAS as additional source of information is intended to widen the MAH’s continuous benefit risk assessment of medicinal products. However, the new responsibilities like monitoring obligations as well as handling complex data sets, represent major challenges. Especially small and medium-sized enterprises (SMEs) are burdened with the heavy workload associated with the collection, review and assessment of the provided information. Therefore, it is crucial to find an approach to select the relevant information avoiding unnecessary steps. This online training course will provide a clear overview on different types of reports that can be retrieved from EVDAS as well as the use of the database regarding different aspects of signal management. Practical tips on analysis of EVDAS outputs (eRMRs & line listings) will be also provided within an interactive session during which the attendees will have the opportunity to ask questions.
The online training course will be subdivided in 2 modules and cover the following aspects:
- 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
Details on the modules are provided underneath – the training course can be subdivided in two 2 hours modules (Modules 1 and 2).
Module 1
The use of EVDAS: how to use EVDAS in the signal management system?
In particular:
- 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
Introduction to EVDAS and on the information that can be retrieved from the database: Active substance grouping, eRMR, Line listing,
What these reports are and why we need them
Module 2
- 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.
Interactive discussions with participants are desired during the online course to share experiences in the daily activities and potential issues/concerns occurring while using EVDAS. A few weeks before starting this training, participants can send specific questions regarding the different aspects proposed in the program in order to productively answer those topics within the webinar. In addition, exercises will be provided to allow participants to put in practice what has been discussed.
This online training targets any person working in pharmacovigilance and who is interested in the use of EVDAS and its application in a signal management system: Qualified Person for Pharmacovigilance (QPPV), Pharmacovigilance Assistants, Advisors and Managers, EudraVigilance Users, Pharmacovigilance Auditors, Professionals belonging to Pharmaceutical Companies, Service Providers (CRO, CSO, Consultants), Biotech Companies and any MAH interested in understanding the role of EVDAS and its use.
This course aimed to provide an overview of what EVDAS can offer and its use in MAH‘s signal management system. Tips and analytical methods will be discussed during this course.
Participant experience
The training is recommended for those who know the Good Pharmacovigilance Practices (GVP) reference (Form VI, V and IX) and having at least 6 months of pharmacovigilance experience.
The online training will be prepared to be interactive and will present both theoretical but also practical aspects of EVDAS. During the different sessions, EVDAS dashboard will be used to allow a true discovery of what EVDAS can offer. Some tips regarding EVDAS data analysis will be also provided.
Docente/i
Harmonie Etienne, Msc
Harmonie completed her studies in biochemistry, molecular & cell biology and molecular physiopathology. After 3 years of research in academics, she followed a training in clinical research and worked in a biotech company in both Clinical Operation and PV Department. Later, she worked as a Project Leader in Pharmacovigilance in a service provider. Then, Harmonie joined emovis GmbH in September 2020 as a Homecare Trial Coordinator for France and Belgium. Her role was to coordinate homecare visits for patients enrolled by Belgian and French sites. In February 2021, she became Homecare Trial Project Manager. She is now responsible of the homecare visit process, from the setup of the study to the close out. She currently manages small teams of homecare Trial Coordinators and is the main point of contact for clients. She is also involved in the continuous development and improvement of internal process.
Online Training – 2 modules
MODULE 1 | 07 April 2021 from10:30 am to 12:30 pm CEST
MODULE 2 | 09 April 2021 from10:30 am to 12:30 pm CEST
After the registration, you will receive all details about the connection.
The course admits maximum 12 attendees.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 460,00* (until 10 March 2021)
Ordinary: € 540,00*
Freelance – Academy – Public Administration**: € 275,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Cosa saprai fare dopo il corso
