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EudraVigilance - electronic reporting of ICSRs in the EEA

Sep 17 2014 9:00AM - Sep 19 2014 5:00PM | HALMED (Agency for Medicinal Products and Medical Devices) Ulica Roberta Frangeša Mihanovica 9 (Sky Office) Zagreb, 100 00 Croatia (Hrvatska)

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Overview 

EudraVigilance is the European data-processing network and management system, established at the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports (ICSRs) related to all medicinal products authorized in the European Economic Area (EEA). EudraVigilance also incorporates signal detection and data analysis facilities and is therefore regarded as one of the main pillars of the European Risk Management Strategy, which aims to strengthen the conduct of pharmacovigilance in the EEA.

Community legislation is in place to ensure that all stakeholders, including National Competent Authorities (NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA collect, collate and exchange adverse drug reactions.

The electronic transmission of ICSRs, based on the results of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) remains a priority in the area of pharmacovigilance to make the adverse reaction data exchange and management more efficient. EVWEB is an Internet-based reporting tool developed by the European Medicines Agency to allow Small and Medium Size Enterprises (SMEs) that hold marketing authorisations in the EEA and sponsors of clinical trials, to report electronically adverse reactions, in full compliance with the internationally agreed standards to the European Medicines Agency and NCAs.

The EudraVigilance Training Programme has been designed for:

  • Organisations e.g. SMEs, (non-) commercial sponsors that intend to use EVWEB to implement electronic transmission of safety data. Organisations intending to use EVWEB are required to follow a training course to ensure the correct use of the reporting tool. They can apply for more than one person to be trained, or alternatively, send one person who will subsequently train other users internally in the organisation.
  • Pharmaceutical companies that perform electronic transmission of ICSRs and use their locally established ICH compliant data-processing network (Gateway) and management system, may wish to attend this course to learn how to access and query the ICSRs that they have submitted to EudraVigilance.
  • National Competent Authorities that wish to acquire knowledge about the functionalities of the tool, specifically in relation to data retrieval and evaluation to facilitate the scientific use of the data contained in the database

Who Should Attend 

The course is intended for people in charge of pharmacovigilance and drug safety in MAHs and National Competent Authorities with legal reporting obligations in the EEA. The target audience of this training course also includes, but is not limited to:

  • Qualified persons for pharmacovigilance
  • Pharmacovigilance experts
  • Data entry professionals
  • Medical coding professionals
  • Persons interested in building or updating their knowledge in electronic adverse reaction reporting

Learning Objectives 

Participants who complete this course should be able to:

  • Apply ICH rules to safety reporting
  • Describe the registration process with EudraVigilance
  • Understand the Concepts of Electronic Transmission of ICSRs
  • Describe the EudraVigilance Gateway
  • Describe the Web Trader functions
  • Explain the reporting processes for fully automated organizations, post-function users, and EVWEB users
  • Create, validate, and send safety messages
  • Create, validate, and send:
    • Follow-up reports
    • Nullification reports
    • Literature reports
    • Parent-child reports
    • Study reports
    • Reports with medical and drug history
  • Apply EudraVigilance business rules
  • Create and send acknowledgments of received ICSR messages
  • Query, view, browse, and download safety reports
  • Query, view, and browse MedDRA through the EVWEB

Featured Topics 

  • Fundamentals of the electronic reporting of ICSRs
  • ICH M2 safety and acknowledgment message specifications
  • ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices as well as the current EudraVigilance Business Rules
  • How to navigate the EudraVigilance system
  • How to enter information into the EudraVigilance system including mandatory fields
  • Training on the Web Trader for transmission of documents on the EudraVigilance Gateway
  • Instruction on using EVWEB to browse MedDRA

Contact Information 

Agenda:
DIA Europe, Middle East and Africa

Kuechengasse 16
4051 Basel
Switzerland
diaeurope@diaeurope.org
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET

For technical questions or registration to EudraVigilance:
EudraVigilance helpdesk for Sponsors
eudravigilance@ema.europa.eu
Eudravigilance registration team
eudravigilanceregistration@ema.europa.eu

Hotel & Travel 

Attendees have to make their own hotel reservation.
Recommended Hotel


Hotel Antunovic
Zagrebacka avenija 100 A
10 000 Zagreb
http://www.hotelantunovic.com/
(about 15 min walking distance to HALMED)


Please contact our local agent if you need help with your hotel and/or flight booking:
OBZOR PUTOVANJA/HOLIDAYS
Teslina 5, 10000 Zagreb, Croatia
Tel. (385) (1) 6160 242
Email: vladimir.mitic@croatiaairlines.hr

Special Offers 

It is not possible to register online for this course. Please fill in the registration form at the back of the pdf programme and send it to the email address indicated.

Faculty 

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Agenda  

Day 1 Wednesday, Sep 17, 2014

  • 9:00AM - 10:30AM (Central European Standard Time)

    Concepts of Electronic Transmission of ICSRs, Introduction to EudraVigilance, Registration with EudraVigilance, Clinical Safety Data Management and Transmission of ICSRs - ICH E2B(R2)
  • 11:00AM - 1:30PM (Central European Standard Time)

    EudraVigilance Gateway and WEB Trader, ICSR Validation Business Rules
  • 1:30PM - 3:30PM (Central European Standard Time)

    Creating a Safety Message, Saving and Printing Options
  • 4:00PM - 6:00PM (Central European Standard Time)

    Follow up and Nullification Report

Day 2 Thursday, Sep 18, 2014

  • 9:00AM - 10:30AM (Central European Standard Time)

    Literature and Parent - child Report, Report with Medical and Drug History
  • 11:00AM - 12:30PM (Central European Standard Time)

    Study Report, EudraVigilance Business Rules
  • 1:30PM - 3:30PM (Central European Standard Time)

    Receiving Acknowledgment Messages, Validation and Creating Acknowledgments
  • 4:00PM - 5:45PM (Central European Standard Time)

    WEB Trader - Post Function, What To Do in the Event of System Failure

Day 3 Friday, Sep 19, 2014

  • 9:00AM - 10:30AM (Central European Standard Time)

    MedDRA Simple and Advanced Queries, ICSR Simple and Advanced Queries
  • 11:00AM - 12:00PM (Central European Standard Time)

    Questions and review for Knowledge Evaluation
  • 1:00PM - 4:00PM (Central European Standard Time)

    Knowledge Evaluation

Registration Fees 

Other Fees

Academia
€865.00
Government (Full Time)
€865.00
Industry
€1745.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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