金曜日, 6月 26, 0021

20090624 EMEA: Revised EMEA Work Instructions (WINs)

24/06/09
Revised EMEA Work Instructions (WINs):
- Organisation of periodic signal detection meetings
- Using EPITT for Signal Management by the EMEA Signal Detection Group
- Searching and Printing CIOMS forms and Line Listings
- Screening Reaction Monitoring Reports for new Signals
- Maintenance of Signal Detection tracking table
- Creating the Signal Detection Reaction Monitoring Report using SAS
- Import of external files and lookup table for the Signal Detection Reaction Monitoring Reports
- Sending Reaction Monitoring Reports to the National Competent Authorities in the EudraVigilance Support Programme
- Creation of Reaction Monitoring Reports for the EudraVigilance Support Programme
- Creation of Medicinal Products Hierarchy for EudraVigilance Data Analysis System using SAS
- Checking licences for parallel distribution
- Determination of the fee for a parallel distribution notification
- Internal Control Mechanism - Decentralised Verification Service

===> EMEA Standard Operating Procedures (SOP) and Work Instructions (WIN)
http://www.emea.europa.eu/htms/general/sop/sop.htm

0 件のコメント: