eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Agenda

Day 1 Oct 22, 2015

9:00 AM — 10:00 AM

Course Introduction/ Introduction to EudraVigilance/ Registration to EudraVigilance

10:00 AM — 11:00 AM

Regulatory Background/ General terms and Definitions

11:00 AM — 11:30 AM

Coffee Break

11:30 AM — 12:00 PM

Operation Types/ Data quality/ Data ownership

12:00 PM — 1:00 PM

Practical examples: how to enter product data in the XEVMPD - Operation type INSERT - organisations & MFL

1:00 PM — 2:00 PM

Lunch Break

2:00 PM — 3:30 PM

Practical examples: how to enter product data in the XEVMPD - Operation type INSERT - AMP

3:30 PM — 4:00 PM

Coffee Break

4:00 PM — 5:30 PM

Practical examples: how to enter product data in the XEVMPD - Operation type INSERT - AMP & DVP, how to validate a XEVPRM, how to view and retrieve a XEVPRM ACK

Day 2 Oct 23, 2015

9:00 AM — 9:30 AM

Review on entering product data in the XEVMPD with Operation type INSERT

9:30 AM — 11:00 AM

Maintenance Operations: how to use operation type UPDATE/ Simple and Advanced queries

11:00 AM — 11:30 AM

Coffee Break

11:30 AM — 1:00 PM

Practical example: how to use the operation type "Invalidate MA" for a AMP

1:00 PM — 2:00 PM

Sandwich Lunch

2:00 PM — 4:00 PM

Knowledge Evaluation: Part 1: Multiple Choice Questions/ Part 2: Product Report Exam Case

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eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Agenda

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