Human
-
List item
Standard operating procedure for tracking and handling in SIAMED of SDA post-authorisation measures for centrally authorised products (PDF/151.45 KB)
Adopted
First published: 11/04/2017
Last updated: 11/04/2017
Legal effective date: 10/04/2017
SOP/H/3441 -
List item
Work instructions for key activities when screening the electronic reaction monitoring reports (eRMRs) for new signals (PDF/306.1 KB)
Adopted
First published: 19/09/2012
Last updated: 19/12/2018
Legal effective date: 06/12/2018
WIN/H/3406 -
List item
Standard operating procedure for handling of safety information from non-EEA regulatory authorities (PDF/118.15 KB)
Adopted
First published: 25/07/2012
Last updated: 06/12/2018
Legal effective date: 28/11/2018
SOP/H/3382 -
List item
Standard operating procedure for evaluation procedure – European Network of Centres for Pharmacoepidemiology and Pharmacovigilance database of research resources (PDF/114.73 KB)
Adopted
First published: 01/12/2011
Last updated: 01/12/2011
Legal effective date: 01/12/2011
SOP/H/3363 -
List item
Standard operating procedure for handling of requests for ADR-related EudraVigilance data (PDF/175.11 KB)
Adopted
First published: 07/01/2019
Last updated: 07/01/2019
Legal effective date: 07/12/2018
SOP/H/3326 -
List item
Standard operating procedure on handling of European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal applications (PDF/269.76 KB)
Adopted
First published: 27/06/2011
Last updated: 27/06/2011
Legal effective date: 24/06/2011
SOP/H/3362 -
List item
Standard operating procedure for European Pharmacovigilance Issues Tracking Tool user registration and management (PDF/269.46 KB)
Adopted
First published: 14/04/2011
Last updated: 20/10/2016
Legal effective date: 12/10/2016
SOP/H/3341 -
List item
Work instructions for user registration and management - Maintenance of the European Pharmacovigilance Issues Tracking Tool (EPITT) accounts and provision of trainings to users (PDF/459.06 KB)
Adopted
First published: 14/04/2011
Last updated: 20/10/2016
Legal effective date: 12/10/2016
WIN/H/3369 -
List item
Work instructions for European Pharmacovigilance Issues Tracking Tool (EPITT) user registration and management – Assessment of eligibility for an EPITT account (PDF/191.01 KB)
Adopted
First published: 14/04/2011
Last updated: 27/10/2016
Legal effective date: 12/10/2016
WIN/H/3367 -
List item
Work instructions on training for signal validators (PDF/102.99 KB)
Adopted
First published: 24/11/2010
Last updated: 07/12/2015
Legal effective date: 07/12/2015
WIN/H/3364 -
List item
Standard Operating Procedure on specific signal detection for situations including a pandemic (PDF/193.45 KB)
Adopted
First published: 29/10/2010
Last updated: 29/10/2010
Legal effective date: 28/10/2010
SOP/H/3317 -
List item
Standard operating procedure on data analysis of EudraVigilance (PDF/127.83 KB)
Adopted
First published: 07/01/2019
Last updated: 07/01/2019
Legal effective date: 17/12/2018
SOP/H/3289 -
List item
Standard operating procedure for signal management (PDF/344.64 KB)
Adopted
First published: 24/06/2009
Last updated: 19/12/2018
Legal effective date: 06/12/2018
SOP/H/3065 -
List item
Standard operating procedure for management of general external pharmacovigilance-related queries assigned to the pharmacovigilance dashboard in JIRA (PDF/135 KB)
Adopted
First published: 23/06/2009
Last updated: 15/01/2016
Legal effective date: 12/01/2016
SOP/H/3293 -
List item
Work instructions for maintenance of signal management tracking table (PDF/431.75 KB)
Adopted
First published: 24/06/2009
Last updated: 19/12/2018
Legal effective date: 06/12/2018
WIN/H/3268 -
List item
Work instructions for review of active substances in products under evaluation in the centralised procedure (from SIAMED listing) (PDF/489 KB)
Adopted
First published: 24/06/2009
Last updated: 14/10/2011
Legal effective date: 12/10/2011
WIN/H/3284 -
List item
Work instructions for validation of signals from the review of individual cases (PDF/152.28 KB)
Adopted
First published: 24/06/2009
Last updated: 06/12/2018
Legal effective date: 29/11/2018
WIN/H/3287 -
List item
Work Instructions for design of an analysis of EudraVigilance data (PDF/109.48 KB)
Adopted
First published: 07/01/2019
Last updated: 07/01/2019
Legal effective date: 17/12/2018
WIN/H/3290