Special Instructions: You are required to bring your own laptop. Course materials will be emailed approximately one week prior to the session.
Facility Entry Requirements
Please plan to arrive 8:30AM.
Upon arrival you will report to the ground floor reception to be issued a visitor pass. Please arrive in good time before the training starts to avoid inconvenience/delays.
You will wait for the host in the lounge located on the ground floor. The host will escort you to the training room.
Please note EMA operates a strict security policy. Failing to respect the rules stated below may result in access to the building being denied.
For your information, external participants entering EMA premises are required to:
Be accompanied by the trainer or a designated staff member at all times to move through the building and to and from the meeting room.
Wear around the neck the lanyard provided with your access card details visible for the duration of your visit to the EMA. (Please, return it to reception desk on your way out).
Remain in the close proximity to the training room during coffee/lunch breaks, i.e. utilise restrooms and break-out areas next to the training room.
In order to respect confidentiality, refrain from entering any meeting rooms, under any circumstances, other than the one designated for the event you are attending.
NOTES:
-- This training will be conducted in English. -- This class is limited to two persons per organisation. However, if space is available, please contact the MSSO training desk, mssotraining@meddra.org, for consideration to add registrants from your company.
Objective:
For participants to review and understand the principles described in the MedDRA Data Retrieval and Presentation: Points to Consider document and to gain an understanding of how and why SMQs have been developed and to appreciate their utility when using databases of MedDRA-coded information.
Description:
This highly interactive 1-day course is designed to provide an overview of the features of MedDRA that relate to the analysis and retrieval of MedDRA-encoded data. The course focuses on the use of MedDRA to retrieve and present aggregated data, based on the principles outlined in the MedDRA Data Retrieval and Presentation: Points to Consider document. Participants will benefit from interactive individual and group exercises in which they will learn how to develop medically meaningful queries for use in their daily work. The course also includes a thorough overview of Standardised MedDRA Queries (SMQs) and their application in the investigation of drug safety issues. Participants learn about the development, testing and maintenance of SMQs and see detailed examples of individual SMQs. Examples of practical applications of SMQs for case identification, safety signal detection, product labeling review, and safety data reporting are presented.
This course is designed for:
Course outline:
Drug safety/pharmacovigilance professionals Clinical monitors Medical writers Data coordinators Clinical programmers Statisticians MedDRA overview MedDRA Data Retrieval and Presentation: Points to Consider document Developing queries using MedDRA Examples and hands-on exercises SMQ background and definition SMQs development status SMQ data characteristics SMQ testing and production maintenance SMQ versioning SMQ applications Customised searches
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