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EudraVigilance - electronic reporting of ICSRs in the EEA

Oct 20 2014 9:00AM - Oct 22 2014 10:00AM | Grand Hotel San Marino V. le A. Onofri San Marino, 47890 San Marino

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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 

DIA Europe, Middle East and Africa

Kuechengasse 16
4051 Basel
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 registration team

Hotel & Travel 

Viale Antonio Onofri, 31
47890 Repubblica di SanMarino – RSM
Phone: +378 0549 992400
Fax: +378 0549.992951
Web: www.grandhotel.sm

The hotels offers a special rate for participants of the EudraVigilance training course:
EUR 82.00 for single occupancy
EUR 102.50 for double occupancy
These rates are per room and night and include buffet breakfast. For hotel bookings please call the hotel or use this booking form.

Travel Information
By Air
"F.Fellini" Airport Rimini-San Marino 27 km www.riminiairport.com
"L.Ridolfi" Airport Forlì 72 km www.forliairport.com
"G. Marconi" Airport Bologna 132 km www.riminiairport.com
By Train
The closest train station is RIMINI RAILWAY STATION
For buses from Rimini to San Marino, please check : http://www.ferroviedellostato.it/homepage_en.html
For more information about San Marino, please consult the following website: http://www.visitsanmarino.com/default.asp?id=81
The hotel organises transfers upon request. Please cotact the hotel.

Special Offers 

A special discount for SMEs is available. To proof your status as an SME, a confirmation of the European Medicines Agency is necessary.


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Registration Fees 

Other Fees

Government (Full Time)
Register Online

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