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WEBINAR: The Use of EudraVigilance Data Analysis System (EVDAS) in the Signal Management System

Date

08 and 10 July 2020

Location

Webinar

Language

English

WEBINAR: The Use of EudraVigilance Data Analysis System (EVDAS) in the Signal Management System

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 on line 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 90 minute-modules (Modules 1 and 2).
Interactive discussions with participants are desired during the on line course to share experiences in the daily activities and potential issues/concerns occurring while using EVDAS. A few weeks before starting this webinar, participants can send specific questions regarding the different aspects proposed in the program in order to productively answer those topics within the webinar. 


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

Webinar Language
The webinar will be in English

Harmonie  Etienne
Harmonie Etienne Project Leader – Pharmacovigilance Advisor at Dr. Ebeling & Assoc. GmbH

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.

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. 

Webinar

Webinar online - 2 modules

July 8th, 2020             11:00 am – 12:30 pm CEST
July 10th, 2020           11:00 am – 12:30 pm CEST

After the registration, you will receive all details about the connection.

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.

Certificate of attendance

Early Bird: € 360,00* (until 17 June 2020)

Ordinary: € 435,00*

Freelance - Academy - Public Administration**: € 174,00*


*
for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

435.00 €

Early Bird

Wednesday, June 17, 2020

360.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 modules of 90 minutes each

Course Type

Limited number of participants

You will receive

Certificate of attendance

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

Participants' Feedbacks

Teacher was very clear  and outstanding  knowledge of the contents 

Choice of topics of great importance for pharmacovigilance activities

I was put at ease during the course and the discussions

Teacher very expert on the subject, available  with the participants, exhaustive in the explanations

Teachers very expert and very good in comunication

Discussion of the topics covered by the course, not only from the Pharmacovigilance point of view, but considering the interactions with other functions / other company departments

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WEBINAR: The Use of EudraVigilance Data Analysis System (EVDAS) in the Signal Management System

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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