Safety reports rmp risk management plan pharmacovigilance

A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.

1. Safety Reports:
RMP: RiskManagement Plan

2. Index
1.What is a Risk Management Plan?
2.Dates of implementation
3.Objective of the RMP
4.Definitions
5.When is a RMP necessary?
6.Structure
SAFETY REPORT: RMP

3. 1. WHAT IS A RISK MANAGEMENT PLAN (RMP)?
A Risk Management Plan is a document based on:
1.Safety profile of the medicine.
2.Plan of all pharmacovigilance activities.
3.Planning and implementation of different measures in order to
minimize risk; and evaluation of effectiveness of those measures.
If you want to get more information check out the following link:
GVP Module V: Risk Management Plan

4. 2. DATES OF IMPLEMENTATION

5. 3. OBJECTIVE OF THE RMP
•Early identification of any risk taking into consideration all the existing
information
•Identification of areas where it is necessary to perform an in depth
evaluation
•Project new studies to characterize and identify scientific-based risks.
•Pharmacovigilance starts before marketing authorization and it
continues during all the life-cycle.

6. 4. DEFINITIONS
•RiskManagementSystem:
Setofactivitiestoidentify,characterize,preventorminimize
anyriskrelatedtomedicinalproducts,includingevaluationof
effectivenessofthesemeasures.
•RiskManagementPlan:
DetaileddescriptionoftheRiskManagementSystem.
Itincludesalltheexistingandmissinginformationaboutthe
safetyprofileofthemedicine;certaintylevelofthe
effectivenessshowninclinicaltrials,measurestopreventany
riskassociatedtothemedicineincludingevaluationof
effectivenessofthesemeasures.

7. 4. DEFINITIONS (2)
•Whatisanimportantidentifiedrisk?
Anadverseeventforwhichthereisenoughevidencetoassociatetherisk
withthemedicine:
•Anadverseeventthatoccursinpre-clinicalandisconfirmedbyclinical
data.
•Anadverseeventidentifiedinclinicaltrialsorepidemiologicalstudies
whenthemagnitudeofthedifferencewiththecomparatorgroup
suggeststhatthereisacausalityrelationship.
•Anadverseeventsuggestedbyalargeamountofwell-documented
spontaneousreactionswithcausalitystronglysupportedby:
❖Temporalrelationship.
❖Biologicalplausability.

8. 4. DEFINITIONS (3)
•Whatisanimportantpotentialrisk?
Anadverseeventforwhichthereisasuspicionofassociationwiththe
medicine,butcausalityisnotconfirmed:
•Pre-clinicaltoxicologicalfindingsthathavenotbeenconfirmedby
clinicaldata.
•Anadverseeventobservedinclinicaltrialsorepidemiologicalstudies
whenthemagnitudeofthedifferencewiththecomparatorgroupisnot
enoughtoestablishacausalityrelationship.
•Asignalobtainedbyspontaneousnotification.
•Aclassefect.

9. 4. DEFINITIONS (4)
•Whatismissinginformation?
Unknowninformationaboutthesafetyofmedicinesrepresentingalimitin
safetydata
Populationsnotstudiedinclinicaltrials:pregnantwomen,patientswith
hepatic/renalfailure,paediatrics,etc.

10. 5. WHEN IS A RMP NECESSARY?
NewMarketingAuthorization,independentlyofitslegaltypeofapplication.
Traditionalherbalproductsandhomeopathicproductsregisteredundera
simplifiedprocedureareexentedtodevelopaRMP.
WhenitisrequiredbyaRegulatoryAgency.

11. 6. STRUCTURE OF A RMP
I.PartI:GeneralOverviewofthemedicine
II.PartII:SafetySpecification
III.PartIII:PharmacovigilancePlan
IV.PartIV:Planforpost-authorisationefficacystudies
V.PartV:RiskMinimisationMeasures
VI.PartVI:SummaryofRMP
VII.PartVII:Annex

12. a. General Overviewof themedicine

13. b. Safety Concerns
Summaryofthesafetyprofile,including
❖ImportantIdentifiedRisks
❖ImportantPotentialRisks
❖Missinginformation
❖Potentialpopulationsat risk
❖Safety gaps thatmustbe underfollow-up

14. c. PharmacovigilancePlan
Theobjectiveof a MAH isto earlyidentifyand/orcharacterizeanypotential
risk.
❖Identifyanynew safety concern
❖Betterunderstandingof knownconcerns
❖Investigateifthoserisksare likelyto be real.
❖To exposehowMAH plansto obtainbetterinformation
Alltheseactivitiescan be:
RoutinePV Activities AdditionalPV Activities

15. d. Post-marketing ResearchPlan
Post-authorisationefficacy studies referto currentindicationsand notto
researchaimedat extendingtheindication.
Summaryfigures of plannedstudies, togetherwiththeagenda and protocols
of alldrafts, shouldbe includedin Annex8 of theRMP.

16. e. RiskMinimizationMeasures
Accordingto thesafety concerns, theMAH mustassesstheneedforrisk
minimizationactivitiesforanyriskincludedin theRMP.
Theseshouldbe consideredona case bycase basis, and theywilldependon
riskseverity, indication, targetedpopulation, etc.
A single riskcan havemore thanoneriskminimizationmeasure.
Eachriskminimizationmeasuremustbe reviewedona regular basisand its
effectivenessmustbe assessed(GVP module XVI).

17. f. Summaryof theRMP
TheRMP PartVI:
•ismadepubliclyavailable, includingkeyfactorsof theRMP and
emphasizingonriskminimizationactivities.
•shouldbe writtenin a non specializedlanguage(lay language)
•describes allriskstakingintoaccountthebenefitsassociatedto the
use of thatmedicine

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