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Electronic reporting of ICSRs in the EEA

Oct 28 2013 9:00AM - Oct 30 2013 4:00PM | INFARMED Parque de Saúde de Lisboa Avenida do Brasil, 53 1749-004 Lisboa Portugal

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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 

Registration and Agenda:
DIA Europe
Kuechengasse 16, Postfach
4002 Basel, Switzerland
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
E-mail: diaeurope@diaeurope.org

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

Hotel & Travel 

Recommended hotels nearby:

VILLA RICA HOTEL
Avenida 5 de Outubro, 295
1600-035 Lisboa
Phone: +351 210 043 000
Fax: +351 210 043 998
http://www.villaricahotelsgroup.com/VillaRica/en/Hotel/VillaRicaLisboa.aspx

RADISSON SAS HOTEL
Av Marechal Craveiro Lopes 390,
1749-009 Lisbon
Phone: 351 (21) 004-5000
Fax: 351 (21) 004-5001
http://www.radissonblu.com/hotel-lisbon

Special Offers 

A special discount for SMEs on the standard rate is available. It is not possible to receive this discount when booking online. To proof your status as SME, a confirmation of the European Medicines Agency is necessary.

Please contact the DIA office(diaeurope@diaeurope.org) for more information.


Agenda  

Day 1 Monday, October 28, 2013

  • 9:00AM - 10:30AM

    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

    EudraVigilance Gateway and WEB Trader, ICSR Validation Business Rules
  • 1:30PM - 3:30PM

    Creating a Safety Message, Saving and Printing Options
  • 4:00PM - 6:00PM

    Follow up and Nullification Report

Day 2 Tuesday, October 29, 2013

  • 9:00AM - 10:30AM

    Literature and Parent - child Report, Report with Medical and Drug History
  • 11:00AM - 12:30PM

    Study Report, EudraVigilance Business Rules
  • 1:30PM - 3:30PM

    Receiving Acknowledgment Messages, Validation and Creating Acknowledgments
  • 4:00PM - 5:45PM

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

Day 3 Wednesday, October 30, 2013

  • 9:00AM - 10:30AM

    MedDRA Simple and Advanced Queries, ICSR Simple and Advanced Queries
  • 11:00AM - 12:00PM

    Questions and review for Knowledge Evaluation
  • 1:00PM - 4:00PM

    Knowledge Evaluation

Registration Fees 

Other Fees

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