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Document(s) Language Status First published Last updated Effective Date
Standard operating procedure for tracking and handling in SIAMED of SDA post-authorisation measures for centrally authorised products (English only) adopted 2017-04-11   2017-04-10
Work instructions on screening electronic reaction monitoring reports (eRMR) for new signals (English only) adopted 2012-09-19   2012-09-19
Standard operating procedure for handling of possible safety signals from other regulatory authorities (English only) adopted 2012-07-25   2012-07-24
Standard operating procedure for evaluation procedure – European Network of Centres for Pharmacoepidemiology and Pharmacovigilance database of research resources (English only) adopted 2011-12-01   2011-12-01
Standard operating procedure for handling of standard requests for data analysis (English only) adopted 2011-09-06 2012-09-26 2012-09-25
Standard operating procedure on handling of European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal applications (English only) adopted 2011-06-27   2011-06-24
Standard operating procedure for European Pharmacovigilance Issues Tracking Tool user registration and management (English only) adopted 2011-04-14 2016-10-20 2016-10-12
Work instructions for user registration and management - Maintenance of the European Pharmacovigilance Issues Tracking Tool (EPITT) accounts and provision of trainings to users (English only) adopted 2011-04-14 2016-10-20 2016-10-12
Work instructions for European Pharmacovigilance Issues Tracking Tool (EPITT) user registration and management – Assessment of eligibility for an EPITT account (English only) adopted 2011-04-14 2016-10-27 2016-10-12
Work instructions on training for signal validators (English only) adopted 2010-11-24 2015-12-07 2015-12-07
Standard Operating Procedure on specific signal detection for situations including a pandemic (English only) adopted 2010-10-29   2010-10-28
Standard operating procedure on handling of request for data analysis clarifying critical aspects of medicines benefit/risk profile (English only) adopted 2010-09-24   2010-09-23
Standard operating procedure for signal management for centrally authorised products (English only) adopted 2009-06-24 2013-03-07 2013-03-07
Standard operating procedure for management of general external pharmacovigilance-related queries assigned to the pharmacovigilance dashboard in JIRA (English only) adopted 2009-06-23 2016-01-15 2016-01-12
Work Instructions for Maintenance of signal detection tracking table (English only) adopted 2009-06-24 2010-02-22 2010-02-22
Work instructions on identification of active substances in products under evaluation in the centralised procedure (from SIAMED listing) (English only) adopted 2009-06-24 2010-11-24 2009-06-24
Work instructions for Population of the Scientific Group table by the Signal Detection and Data Analysis secretary (English only) adopted 2009-06-24 2010-02-22 2010-02-22
Work instructions for review of active substances in products under evaluation in the centralised procedure (from SIAMED listing) (English only) adopted 2009-06-24 2011-10-14 2011-10-12
Work instructions for evaluation, validation, prioritisation and reporting signals from the review of Council for International Organizations of Medical Sciences forms and line listings (English only) adopted 2009-06-24 2011-09-16 2011-09-15
Work Instructions for validation and interpretation of data analysis conducted on EudraVigilance (English only) adopted 2010-09-24   2010-09-23