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Risk Management Plan: By: Turacoz Healthcare Solutions
Risk Management Plan: By: Turacoz Healthcare Solutions
Risk Management Plan: By: Turacoz Healthcare Solutions
WHAT IS RMP?
Risk management plan (RMP) is a regulatory document
required for submission to health authorities
Includes information on:
a medicine's safety profile
how its risks will be prevented or minimised in patients
plans for studies and other activities to gain more
knowledge about the safety andefficacyof the
medicine
risk factors for developing adverse reactions
measuring the effectiveness of risk-minimisation
measures
IMPORTANT DEFINITIONS
Identified risk
An untoward occurrence for which there is adequate evidence
of an association with the medicinal product of interest
Potential risk
An untoward occurrence for which there is some basis for
suspicion of an association with the medicinal product of
interest but where this association has not been confirmed
Missing information
Gaps in knowledge about a medicinal product, related to
safety or use in particular patient populations, which could be
clinically significant.
Product(s) overview
Part II
Safety specification
Part III
Pharmacovigilance plan
Part IV
Part V
Risk minimisation measures (including evaluation
of
the effectiveness of risk minimisation
measures)
Part VI
Part VII
Module SIII
Module SIV
Module SV
Post-authorisation experience
Module SVI
Module SVII
Module SVIII
THANKS