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EudraVigilance - electronic reporting of ICSRs in the EEA

Nov 17 2014 9:00AM - Nov 19 2014 5:00PM | European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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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 

    HOTEL INFORMATION
    Attendees are kindly requested to make their own reservation. Recommended hotel:

    Hilton London Docklands Riverside
    265 Rotherhithe Street
    London SE16 5HW
    Tel: +44 20 7231 1001
    Fax: +44 20 7231 0599
    Email: reservations.docklands@hilton.com

    Special negotiated DIA rate for participants of the EudraVigilance courses is GBP 139.00 per single room incl. breakfast and VAT (GBP 149.00 for double occupancy). Please book your room at least 30 days before arrival through this link.
    For reservations after that date, please contact Beatriz Martinez at: beatriz01.martinez@Hilton.com
    The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. 

    TRAVEL INFORMATION
    The European Medicines Agency (EMA) is moving in summer 2014. The course takes place in the new offices at:
    30 Churchill Place
    Canary Wharf
    E14 5EU London
    Website:www.ema.europa.eu
    Closest DLR and tube (Jubilee line) station is Canary Wharf. Pease calculate a delay of 05-10 minutes to enter the EMA building (special security procedure) and note that it is not possible to enter the building before 8.00 am.

    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.

    Faculty 

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    Agenda  

    Day 1 Saturday, Oct 25, 2014

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

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

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

      Follow up and Nullification Report

    Day 2 Sunday, Oct 26, 2014

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

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

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

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

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

    Day 3 Monday, Oct 27, 2014

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

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

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