Agenda
8:45 AM — 9:15 AM
9:15 AM — 10:00 AM
10:00 AM — 10:45 AM
11:00 AM — 12:30 PM
1:30 PM — 5:45 PM
8:45 AM — 9:30 AM
9:30 AM — 11:00 AM
11:30 AM — 1:30 PM
2:30 PM — 5:00 PM
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Course Introduction, Introduction to EudraVigilance, Registration to EudraVigilance
Regulatory Background, General Terms and Definitions, eXtended EudraVigilance Medicinal Product Report Message, (XEVMPRM) Data Set, Operation Types, Data Quality, Data Ownership
Database Architecture, Roles of the eXtended EudraVigilance Medicinal Product, Dictionary (XEVMPD) within EudraVigilance, Data Collection Process
How to enter product data in the XEVMPD using the EVWEB tool, How to enter an organisation (MAH and Sponsor), How to enter a substance (an approved and a development substance), translations and synonyms
Examples of different types of authorised medicinal products, Nationally authorised medicinal product, Medicinal product authorised through the mutual recognition procedure, Centrally authorised medicinal product, Investigational Medicinal Product (Develo
How to perform simple and advanced queries in the XEVMPD using the EudraVigilance Web-based application (EVWEB)
How to maintain product data in the XEVMPD using EVWEB, How to use the operation type “withdraw” for an authorised medicinal product
Example how to use the operation type “update” for substance (including the handling of translations and synonyms), Example how to use the operation type “update” for an organisation
Knowledge Evaluation, Part 1: Multiple Choice Questions, Part 2: Product Report Exam Case