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Electronic Reporting of ICSRs in the EEA

Nov 28 2012 8:30AM - Nov 30 2012 4:30PM | DIA 800 Enterprise Rd Ste 200, Horsham, PA 19044-3509 USA

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Overview 

This course is for those in charge of pharmacovigilance and drug safety within Marketing Authorization Holders (MAHs) and National Competent Authorities (NCAs) with legal reporting obligations to the European Economic Area (EEA).
Note: The course will NOT address aspects related to the data entry of medicinal product information in the EudraVigilance Medicinal Product Dictionary (EVMPD). Personnel of organizations responsible for entering medicinal product data in the EVMPD should attend the EVMPD training course.

Who Should Attend 

  • 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
  • Contract research organizations

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 organisations, 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 

  • EudraVigilance registration process
  • Electronic transmission of Individual Case Safety Reports (ICSRs)
  • EudraVigilance Gateway
  • Web trader functions
  • Reporting processes for fully automated organizations, post-function users, and EVWEB users
  • Applying ICH rules to safety reporting
  • Creating, validating, and sending safety messages
  • Applying EudraVigilance business rules
  • Creating and sending acknowledgments of received ICSR messages
  • Querying, viewing, browsing, and downloading safety reports
  • Querying, viewing, and browsing MedDRA through the EVWEB
  • Creating, validating, and sending follow-up reports, nullification reports, literature reports, parent-child reports, study reports, and reports with medical and drug history

Contact Information 

Registration
Elizabeth Espich
Phone: +1-215-293-5802
Email: Elizabeth.Espich@diahome.org
Agenda and Event Details
Susan Berkelbach
Phone: 1-215-442-6183
Email: Susan.Berkelbach

Eudravigilance helpdesk: eudravigilance@ema.europa.eu
Registration team: eudravigilanceregistration@ema.europa.eu

Hotel & Travel 

Training Course Location
DIA Worldwide Headquarters
800 Enterprise Road, Suite 101
Horsham, PA 19044
Courtyard Philadelphia Montgomeryville
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until July 29, 2012, or until room block is filled). Attendees should make airline and room reservations as soon as possible.
Standard Room Rate
$165
Address: 544 Dekalb Pike, North Wales, PA 19454
Phone: +1-215-699-7247
When making reservations, mention the DIA training course.
The Courtyard Philadelphia Montgomeryville is on Route 202 just off Route 309, with quick access to the course location in Horsham, PA. The hotel has an indoor pool, spa, gym, wireless Internet access, and a breakfast buffet. Restaurants are within walking distance.

Faculty 

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Registration Fees 

Other Fees

Standard
$2300.00
Group Discounts

There are no Group Discounts for this activity.


Cancellations:  Cancellations must be received two weeks prior to the first day of the course.  A $200 administrative charge will be deducted from the original registration fee.  Cancellations must be in writing and received in the DIA office according to the timeline above.  There will be no refund if cancellation is received with two weeks from the first day of the course.  Registrants are responsible for cancelling their own hotel and travel reservations.  Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee.  DIA reserves the right to alter the venue, if necessary.  If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants. 

Transfers:  You may transfer your registration to a colleague at any time but membership is not transferable.  Please notify the DIA North American office of such transfers in writing as soon as possible.  Substitute registrants will be responsible for the nonmember fee, if applicable.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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