ID Pharma has its own Pharmacovigilance system described with
PSMF as well as a qualified person responsible for pharmacovigilance
(QPPV) and her deputy (Deputy QPPV), which opens opportunities for:
Registration of medicinal products using the pharmacovigilance system
and the qualified person responsible for pharmacovigilance (QPPV) provided by ID Pharma;
Taking over of the obligations of the MAH in the field of pharmacovigilance
in the period during and after product authorization (fully or partially), including:
registration in the EudraVigilance system (ID Pharma possesses appropriate user
certificates);
preparation of selected procedures describing pharmacovigilance activities
or a set of procedures in line with the processes required in pharmacovigilance;
preparation of a complete description of the adverse drug reaction monitoring system
(PSMF) tailored to the needs of the company and a summary description (SPS) required in
the
registration processes;
preparation of xEVMPD (extended Eudravigilance Medicinal Product Dictionary - in
accordance
with Article 57(2) of Regulation (EC) No. 726/2004
risk analysis of the implemented pharmacovigilance system and its adjustment to the
structure of organization and legal requirements;
preparing the company for the Pharmacovigilance inspection;
management of observations / deficiency after the inspection (CAPA preparation according
to
the "Deficiency Letters");
preparation of documentation: periodic reports, RMP with risk minimization, Clinical
Expert
Statement, Addendum to the Clinical Overview;
preparation of a risk minimization proposal;
we ensure 24-hour accessibility in order to report adverse drug reaction;
processing of adverse drug reaction reports including medical evaluation;