title form document refers document title

1. Identification of active substances in products WIN/H/3280 SOP/H/3275 Population and

under evaluation in the centralised procedure maintenance of the
(from SIAMED listing) Scientific Group table
for
Active Substances in
Centrally Authorised
Products or in products
under evaluation in the
Centralised
Procedure.
2. Population of the Scientific Group table by the WIN/H/3282 SOP/H/3275 Population and
Signal Detection and Data Analysis Secretary maintenance of the
Scientific Group table
for
Active Substances in
Centrally Authorised
Products or in products
under evaluation in the
Centralised
Procedure.
3. WIN/H/3284 SOP/H/3275 Population and
Review of active substances in products under maintenance of the
evaluation in the centralised procedure (from Scientific Group table
SIAMED listing) for
Active Substances in
Centrally Authorised
Products or in products
under evaluation in the
Centralised
Procedure.
4.
Training for signal management leads WIN/H/3364
Memorandum IAP-A13003-4-03 Management of
 scientific and regulatory
training within the P-
division

5.
Evaluation, validation, prioritisation and WIN/H/3287 SOP/H/3065
reporting signals from the review of CIOMS
forms and line listings

EPITT user registration and management WIN/H/3369

Maintenance of the EPITT accounts
Validation and interpretation of data analysis WIN/H/3290 EDMS under the pharmacovigilance folder
conducted on EudraVigilance (09 PHV):
documentum\Docbases\EDMS\Products\H-
C\A-Z\Product-000XXX\09 PHV

EPITT user registration and management WIN/H/3367 SOP/H/3341 EPITT User Registration
Assessment of eligibility for an EPITT account and Management
Maintenance of Signal Detection MAnagement WIN/H/3368 SOP/H/3065 Periodic signal
detection for centrally
approved products
based on reaction
monitoring control
Periodic signal
Screening electronic reaction monitoring WIN/H/3406 SOP/H/3065 detection for centrally
reports (eRMR) for new signals authorised products
based on reaction
monitoring reports -
which states that the
screening of the eRMR
is performed by SVT
members.
Evaluation, validation,
WIN/H/3287 prioritisation, and
reporting signals from
the review of CIOMS
forms