EudraVigilance Eğitim Programı

EudraVigilance Eğitim Programı…

EudraVigilance Training Programme

• Introduction and Available Training Courses
  1. Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) for the use of Eudravigilance
  2. EudraVigilance – electronic reporting of ICSRs training
  3. eXtended EV Medicinal Product Dictionary (XEVMPD)
     • XEVMPD e-learning course
  4. EV Data Analysis System (EVDAS) Training for National Competent Authorities
• Available Training Dates
• Training FAQs

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-Learning Course

Electronic submission of information on medicines – New pharmacovigilance legislation (Art. 57, paragraph 2, 2nd sub-paragraph, Regulation (EC) No. 726/2004).

Overview of the e-learning course

The European Medicines Agency (EMA) has prepared the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning course to facilitate the practical implementation of the electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) in the context of the new pharmacovigilance legislation.

The e-learning course provides self-paced learning activities focusing on the explanation of the business requirements, technical aspects and operational procedures for the electronic submission of information on medicines. It provides guidance on the mandatory data elements necessary for the generation of eXtended EudraVigilance Product Report Messages (XEVPRMs) and outlines the use of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data entry tool also known as EVWEB.

After finishing this e-learning course, an XEVMPD knowledge evaluation can be performed. If this knowledge evaluation is perfomed successfully, the EMA will provide the user with a notification of successful completion of the XEVMPD knowledge evaluation.

At least one user from each marketing authorisation holder should be trained to understand how to submit medicinal product data to the Agency and to ensure quality of medicinal product data submitted to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). A notification of successful completion of the XEVMPD knowledge evaluation will be required for one user before the electronic submission process can be initiated by an MAH

This e-learning course does not cover:

• Training in developing and validating information or communication technology tools to produce messages compliant with the published XEVPRM and SSI XSD schemas
• Training on all five ISO Identification of Medicinal Products (IDMP) standards and the Individual Case Safety Report (ICSR) standard as well as related ICH Implementation Guides
• Training on IDMP, ICSR and Common Product Model (CPM) HL7 messages

How to access the XEVMPD e-Learning Course

The XEVMPD e-Learning course is freely accessible via the following methods:

1. Streaming via YouTube (recommended)
2. Downloading the videos
3. Podcast via iTunes or RSS

XEVMPD e-Learning Course Content

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual is available here

How to obtain a notification of successful completion of the XEVMPD knowledge evaluation

A notification of successful completion of the XEVMPD knowledge evaluation can be obtained from the Agency after successful completion of the XEVMPD knowledge evaluation.

Due to a high demand for the XEVMPD e-learning knowledge evaluation, we are currently able to accept registrations for this XEVMPD e-learning knowledge evaluation from two persons from each organisation before 2 July 2012. Additional persons from the same organisation can register for the XEVMPD e-learning knowledge evaluation after 2 July 2012.

Please note that a person, who already holds the Notification of successful completion of the XEVMPD knowledge evaluation can train additional EV web users with XEVMPD data entry rights from the same organisation.

Participants need to register for the XEVMPD knowledge evaluation. To register, please contact [email protected]

The XEVMPD knowledge evaluation consists of two parts:

• Part I: Multiple Choice Questionnaire
  Participants will be asked to answer 20 questions. There is one correct answer for each question. At least 16 questions (=80%) have to be answered correctly to receive a passing score.
• Part II: Product Report Exam Case
  Participants will receive a password and username that will allow them access to the training environment of the XEVMPD. This access is limited to 4 weeks. In this part of the knowledge evaluation, participants will be requested to enter a fictitious Product Report Message to the XEVMPD training environment on the basis of the supporting documents received together with the login details.

Participants have three attempts to pass each section of the knowledge evaluation.

How to register with the XEVMPD production environment

Before starting the electronic submission of information on medicines, the necessary registration process needs to be followed

Upon receipt of the notification of successful completion of the XEVMPD knowledge evaluation from the Agency, the MAH or Sponsor needs to contact the EudraVigilance registration team at [email protected] to be registered within the XEVMPD community to be able to electronically submit information on medicinal products using the new XEVPRM format.

Full details of the registration process are available at Registration for EudraVigilance.

NOTE: Participants that already hold a previously issued (X)EVMPD certificate need to upgrade their registration profile to be added to the XEVMPD community by contacting the EudraVigilance registration team at [email protected]. Such request needs to be made before starting with the electronic submission of information on medicinal products using the new XEVPRM format.