×GetadviceResearch&ArticlesAllCategoriesForVendorsAboutUsForfreesoftwareadvice,callusnow!855-998-8505Research&ArticlesAllCategoriesForVendorsAboutUsGetadvice—it'sfreeFollowthe5StepsoftheRiskManagementProcesstoBuildaPlanforYourBusinessBy:OliviaMontgomery,PMPonOctober9,2020FEMAreportsthat40to60%ofsmallbusinessesneverreopentheirdoorsafteranaturaldisaster.AppRiver’sCyberthreatIndexofBusinessSurveyreportsthat48%ofsmalltomidsizebusinessessayamajordatabreachwouldlikelyshutdowntheirbusinesspermanently.Scarystuff.Butifyou’reprepared,you’renotdoomed.Astrongriskmanagementplancanhelpyourbusinessmitigateandplanforsuchrisksandkeepyouontheotherendofthosestatistics.Andyoudon’tneedtobestressedaboutcreatingthisplan.Theriskmanagementprocessdoesn’tnecessarilyneedtobeconductedbyariskmanageroranexpensiveriskmanagementconsultant.Youcancreateaninformedandstrongplanbyfollowingthestepswe’lloutlinebelow.Inthisarticle,we’llgooverthefivestepsoftheriskmanagementprocessandexplainthepurposeofeach,offerquestionstoaskyourselftogetstarted,andsharetips.Thisisahigh-leveloverview,intendedtohelpyoucreateasimpleriskmanagementplanforyoursmallbusiness.Note:Riskmanagementcangetextremelycomplexwithexercisessuchasadvancedimpactcalculationsandin-depthroot-causeanalysis.Ifyouhavealargerbusinesses,areinahigh-riskindustrysuchasfinance,orareapublicly-heldcompany,youmayneedanenterpriseriskmanagementsoftwaresolutiontomanageamatureriskmanagementstrategy.Whatisriskmanagement?Beforewediveintotheprocess,let’stakeastepbackanddefineriskmanagement:Riskmanagementistheactofidentifying,evaluating,planningfor,andthenultimatelyrespondingtothreatstoyourbusiness.Thegoalistobepreparedforwhatmayhappenandhaveaplaninplacetoreactappropriately.Ifyou’renewtoriskmanagementpracticesorfeellikeyouneedarefresher,werecommendcheckingout“WhyRiskManagementIsImportantandHowSoftwareCanHelp.”Init,weexplainexactlywhatariskmanagementplanisandtakeyouthroughanexampleofabusinessownerdevelopingariskregisterandplan.Whatarethefivestepsoftheriskmanagementpro

Whatisariskmanagementplan?PublishedMarch25,2019•ByTheaGarcia•2minreadAriskmanagementplanisawrittendocumentthatdetailstheorganization’sriskmanagementprocess.Thisprocessstartsbycreatingateamofstakeholderacrosstheorganizationtoreviewpotentialriskstotheorganization.Thisstakeholderteamshouldincludeseniormanagement,thecomplianceofficer,andanydepartmentmanagers.Iftheorganizationisdevelopingsoftware,thenoneprojectmanagerfromeachprojectteamshouldalsobeincludedtoreviewprojectmanagementandrespondtoprojectrisks.Oncecreated,theteamcanbeginworkingontheriskmanagementprocess.SetObjectivesFirst,theteammembersneedtoreviewbusinessobjectives,suchasproductdevelopmentorthird-partybusinesspartnerships.Bystartingwithbusinessobjectives,theriskmanagementprocessalignstocurrentaswellasfuturegoals.RiskIdentificationThesecondstepincreatingariskmanagementplanliesinreviewingdigitalassetssuchassystems,networks,software,devices,vendors,anddata.Catalogingtheseassetsthenallowstheteammemberstoidentifyriskstotheassets.Arisk,oruncertainevent,canbeapositiveornegativeconditionthathasafinancial,operational,orreputationalimpact.RiskAssessmentAfteridentifyingrisks,theriskmanagementteamneedstoassesstherisk.Positiverisks,suchasearlyproductdelivery,canalsoleadtonegativerisks,suchasacustomer’sinabilitytomeetapaymentschedule.Theorganizationneedstoforeseerisksinordertofindawaytoanalyzetheirpotentialimpact.RiskAnalysisForeachriskidentifiedandassessed,theteammustlookatthelikelihoodtheeventwilloccurandthenestimateimpactstothebusinessifitdoesoccur.Multiplyinglikelihoodbytheestimatedimpactcangiveinsightintoarisk’seffect.Ariskwithalowlikelihoodleadstoadevastatingfinancialimpact.Meanwhile,ariskwithahighlikelihoodmayhavenoimpact.Partofthequantitativeorqualitativeanalysisiscreatingtheriskassessmentmatrix.Thisallowstheriskmanagementteamtousetheriskanalysisandassignratingssuchashigh,medium,orlow. RiskToleranceAfterassigningriskratings,theteamworkstodeterminewhetheritwillaccept,transfer,mitigate,orrefusearisk.Theteammaydecidet

Risk management plan process · Step 1: Identify potential risks · Step 2: Evaluate and assess potential risks · Step 3: Assign ownership for each potential risk · Step 4 ...SkiptomaincontentSearchHowtoCreateaRiskManagementPlanTheword“risk”evokesmanyreactions.Forsome,itconjuresaterrifyingunknown.Forothers,itservesasanexcitingmotivator.Regardlessofyourpersonalconnotationofrisk,everyprojectmanagerneedstogetcomfortableplanningforandconfrontingriskheadonbycreatingariskmanagementplan.TakeaproducttourWhywriteariskmanagementplan?Inhisbook,DoneRight,WorkfrontCEOAlexShootmanpointsoutthatyoucan’tandwon’twinallthetime.“Tosucceed,youmustfacetheriskoffailureandberesilienttowhatevercomesoutofleftfield...Whatkeepsmegoingintoughtimesistheknowledgethatsuccesstomorrowlivesontheothersideoftoday’sfailure.There’salwaysanotherchancetowin.”TheresiliencythatShootmandescribesismadepossiblebyprojectriskmanagement.Weencounterandplanforrisksineverypartofourlives,frombuyingdisasterinsurancetopracticinganevacuationplan.Wecan’tpredictexactlywhatwillhappen,orwhenariskwillpresentitself,butwecanuseourexperience,wisdom,research,andforesighttoremainaspreparedaspossibleandkeepourcoolwhenrisksmaterialize.UnderstandingprojectrisksTostartwritingariskmanagementplan,let’sfirstlookatahelpfuldefinitionofprojectriskfromAGuidetotheProjectManagementBodyofKnowledge(PMBOK®),2000Edition:“...ariskisanuncertaineventorconditionthat,ifitoccurs,hasapositiveornegativeeffectonaprojectobjective.Thusariskisnotaneventoroccurrencewhichhasalreadybefallenaproject.Itisaneventthatmighthappen.” Somethingthathasalreadyhappenedisaprojectissuethatyoumustactivelyrespondto.Contrarily,aprojectriskissomethingwiththepotentialtooccurthatyoumustremainpreparedfor. The3elementsofeveryriskGregoryBeckerdistinguishestheriskeventfromtwoothercrucialcomponentstoeveryrisk:Theriskitselfistheeventorconditionthatmayhappen.Theriskshouldbeclearlydefinedsothattheconcernismaderealandcanberespondedto. Theconsequenceofariskmustalsobedefinedsoyourteamknowswhat

RiskmanagementplanFromWikipedia,thefreeencyclopediaJumptonavigationJumptosearchThisarticleneedsadditionalcitationsforverification.Pleasehelpimprovethisarticlebyaddingcitationstoreliablesources.Unsourcedmaterialmaybechallengedandremoved.Findsources: "Riskmanagementplan" – news ·newspapers ·books ·scholar ·JSTOR(November2007)(Learnhowandwhentoremovethistemplatemessage)Ariskmanagementplanisadocumentthataprojectmanagerpreparestoforeseerisks,estimateimpacts,anddefineresponsestorisks.Italsocontainsariskassessmentmatrix.Ariskis"anuncertaineventorconditionthat,ifitoccurs,hasapositiveornegativeeffectonaproject'sobjectives."[1]Riskisinherentwithanyproject,andprojectmanagersshouldassessriskscontinuallyanddevelopplanstoaddressthem.Theriskmanagementplancontainsananalysisoflikelyriskswithbothhighandlowimpact,aswellasmitigationstrategiestohelptheprojectavoidbeingderailedshouldcommonproblemsarise.Riskmanagementplansshouldbeperiodicallyreviewedbytheprojectteamtoavoidhavingtheanalysisbecomestaleandnotreflectiveofactualpotentialprojectrisks.Mostcritically,riskmanagementplansincludeariskstrategy.Contents1Riskresponse2Examples3Seealso4References5ExternallinksRiskresponse[edit]Mainarticle:Riskmanagement§ PotentialrisktreatmentsBroadly,therearefourpotentialresponsestoriskwithnumerousvariationsonthespecifictermsusedtonametheseresponseoptions:[2][3]Avoid–Changeplanstocircumventtheproblem;Control/mitigate/modify/reduce–Reducethreatimpactorlikelihood(orboth)throughintermediatesteps;Accept/retain–Assumethechanceofthenegativeimpact(orauto-insurance),eventuallybudgetthecost(e.g.viaacontingencybudgetline);orTransfer/share–Outsourcerisk(oraportionoftherisk)toathirdpartyorpartiesthatcanmanagetheoutcome.Thisisdonefinanciallythroughinsurancecontractsorhedgingtransactions,oroperationallythroughoutsourcinganactivity.(Mnemonic:SARA,forShareAvoidReduceAccept,orA-CAT,for"Avoid,Control,Accept,orTransfer")Riskmanagementplansoftenincludematrices.Examples[edit]TheUnitedStatesDepartmentofDefense,aspartofacquis

A risk management plan is a written document that details the organization's risk management process. This process starts by creating a team ...Whatisariskmanagementplan?PublishedMarch25,2019•ByTheaGarcia•2minreadAriskmanagementplanisawrittendocumentthatdetailstheorganization’sriskmanagementprocess.Thisprocessstartsbycreatingateamofstakeholderacrosstheorganizationtoreviewpotentialriskstotheorganization.Thisstakeholderteamshouldincludeseniormanagement,thecomplianceofficer,andanydepartmentmanagers.Iftheorganizationisdevelopingsoftware,thenoneprojectmanagerfromeachprojectteamshouldalsobeincludedtoreviewprojectmanagementandrespondtoprojectrisks.Oncecreated,theteamcanbeginworkingontheriskmanagementprocess.SetObjectivesFirst,theteammembersneedtoreviewbusinessobjectives,suchasproductdevelopmentorthird-partybusinesspartnerships.Bystartingwithbusinessobjectives,theriskmanagementprocessalignstocurrentaswellasfuturegoals.RiskIdentificationThesecondstepincreatingariskmanagementplanliesinreviewingdigitalassetssuchassystems,networks,software,devices,vendors,anddata.Catalogingtheseassetsthenallowstheteammemberstoidentifyriskstotheassets.Arisk,oruncertainevent,canbeapositiveornegativeconditionthathasafinancial,operational,orreputationalimpact.RiskAssessmentAfteridentifyingrisks,theriskmanagementteamneedstoassesstherisk.Positiverisks,suchasearlyproductdelivery,canalsoleadtonegativerisks,suchasacustomer’sinabilitytomeetapaymentschedule.Theorganizationneedstoforeseerisksinordertofindawaytoanalyzetheirpotentialimpact.RiskAnalysisForeachriskidentifiedandassessed,theteammustlookatthelikelihoodtheeventwilloccurandthenestimateimpactstothebusinessifitdoesoccur.Multiplyinglikelihoodbytheestimatedimpactcangiveinsightintoarisk’seffect.Ariskwithalowlikelihoodleadstoadevastatingfinancialimpact.Meanwhile,ariskwithahighlikelihoodmayhavenoimpact.Partofthequantitativeorqualitativeanalysisiscreatingtheriskassessmentmatrix.Thisallowstheriskmanagementteamtousetheriskanalysisandassignratingssuchashigh,m

In the most basic terms possible, a risk management plan is a document used by project managers to identify potential risks to the project, ...WhatisPlanio?Planio+FeaturesPricing&SignUpSecurityAboutusSupportLoginNo1inRedmineHostingREDMINE«BacktoPlanioBlogJoryMacKayonApril03,2020TwittericonFacebookiconLinkedIniconXingiconJoryMacKayJoryisawriter,contentstrategistandaward-winningeditoroftheUnsplashBook.HecontributestoInc.,FastCompany,Quartz,andmore.April03,2020·11minreadWhenyoufailtoplan,you’replanningtofail.Asaprojectmanager,youofallpeopleknowthetruthofthisoldadage.Poorplanningisattherootofmostprojectfailures.Butwhileit’seasytoplanforpositiveoutcomes(likemilestones,OKRs,andsuccessmetrics),it’snotalwayseasytoplanfortheworst.GetyourfreetemplateandcreateyourownriskmanagementplanWehavedesignedaneasytouseRiskManagementTemplateforyoutouseforfree.GetyourfreetemplateWe’dallliketothinkthatourprojectwillgosmoothly.Butignoringpotentialrisksisn’tjustbeingoverlyoptimistically.It’sdownrightdangerous.Infact,nearly⅓ofallprojectfailuresareduetoundefinedrisks!Thebasics:Whatisriskmanagement,anyway?Whatsortofrisksdoyouneedtothinkabout?Foreachrisk,thereare3levelsofknowabilitytoconsiderThe7stepstocreatingaproperprojectriskmanagementplan1.Riskanalysis:Identifypotentialrisks(andthendocumentandprioritizethem)2.Evaluateandassesstheconsequence,impact,andprobabilityofeachpotentialrisk3.Assignrolesandresponsibilitiestoeachrisk4.Comeupwithpreventativestrategiesforeachrisk5.Createacontingencyplanincasethingsgoreallywrong6.Measureyourriskthresholdandworkwithprojectstakeholders7.ContinuetomonitorandreportoneachriskHowtocreateapowerfulriskmanagementsystemusingPlaniowikisandtasksPlanningforfailureisactuallyplanningtosucceedAprojectriskmanagementplanisadocumentthathelpsyouidentify,evaluate,andplanforpotentialissuesthatcouldcomeupduringyourproject.It’slikearoadmapthatshowsyoueverypotholeandaccident-pronecorneronyourpathsoyoucanavoid,re-route,or,atthebareminimum,bereadyforwhatever’scomingyourway.Inthispos

Elements of a Risk Management Plan · 1. Identify Risks · 2. Map Out Impact Versus Likelihood · 3. Plan Your Risk Response · 4. Assign an Owner to ...SkiptoContentProjectManagementByAlyssaScavetta   |   Dec3,2019Youidentifythem,recordthem,monitorthemandplanforthem:risksareaninherentpartofeveryproject.Somerisksareboundtobecomeproblemareas—likeexecutingaprojectovertheholidaysandhavingtoplantheprojecttimelinearoundthem.Buttherearemanyriskswithinanygivenprojectthat,whenunchecked,cancomeasunwelcomesurprisestoyouandyourteam.That’swhereariskmanagementplancomesin—tohelpmitigaterisksbeforetheybecomeproblems.Butfirst,whatisriskmanagement?Manageriskwithconfidence.UseProjectManager.com’sdashboardsandtakeyourriskmanagementtothenextlevel!WhatisRiskManagement?Riskmanagementisanarmofprojectmanagementthatdealswithmanagingpotentialimpactstoyourproject,bothpositiveandnegative.Managingyourrisksisarguablyoneofthemostimportantpartsofaproject.Ifoneriskthat’spassedyourthresholdhasitsconditionsmet,itcanputyourentireprojectinjeopardy.Thereisn’tusuallyjustoneriskperproject,either;therearemanyrisksthatrequireassessmentanddiscussionwithyourstakeholders.That’swhyriskmanagementneedstobebothaproactiveandreactiveprocessofidentifying,analyzingandrespondingtorisksthatemergeoverthelifetimeoftheproject.It’ssomethingthatoccursbothattheoutsetoftheprojectandthroughouttheentiretyoftheprojectlifecycle,ensuringthatnothingcropsupoutoftheleftfield.ElementsofaRiskManagementPlanForeverywebdesignanddevelopmentproject,constructionprojectorproductdesign,therewillberisks.That’strulyjustthenatureofprojectmanagement.Butthat’salsowhyit’salwaysbesttogetaheadofthemasmuchaspossiblebydevelopingariskmanagementplan.Therearetypicallyahandfulofelementsthatmakeupariskmanagementplan,andtheyareoutlinedbelow.1.IdentifyRisksRiskidentificationoccursatthebeginningoftheproject,aswellasthroughouttheproject.Whilemanyrisksareconsidered“knownrisks”,othersmightrequireadditionalresearchtodiscover.Toidentifyrisks,createariskidentificationchec

Thursday,June3,2021NoResultViewAllResultNEWSLETTERHomeAboutAboutCCIWritingforCCINEW:CCIPress–BookPublishingAdvertiseWithUsTopicsSeeAllArticlesComplianceEthicsRiskFCPAGovernanceFraudInternalAuditHRComplianceCybersecurityDataPrivacyFinancialServicesLeadershipandCareerVendorNewsJobsCompliance&RiskInformationSecurityEventsCalendarOn-DemandWebinarsSubmitanEventDownloadseBooksWhitepapersPodcastsVideosSubscribeHomeAboutAboutCCIWritingforCCINEW:CCIPress–BookPublishingAdvertiseWithUsTopicsSeeAllArticlesComplianceEthicsRiskFCPAGovernanceFraudInternalAuditHRComplianceCybersecurityDataPrivacyFinancialServicesLeadershipandCareerVendorNewsJobsCompliance&RiskInformationSecurityEventsCalendarOn-DemandWebinarsSubmitanEventDownloadseBooksWhitepapersPodcastsVideosSubscribeNoResultViewAllResultHomeRiskKeyElementsoftheRiskManagementProcessbyJimDeLoachJanuary10,2018inRiskWhatarethekeyelementsoftheriskmanagementprocess?It’sagreatquestion—andanimportantone—sincecraftinganeffectiveriskmanagementprogramprotectsacompany’sreputationandcanevengiveitacompetitiveedgeinthemarketplace.Likeanyotherworthwhilebusinessactivity,riskmanagementrequiresaprocesswithaclearpurpose,reliableinputs,well-designedactivitiesandvalue-addedoutputs. Here’swhat toconsiderwhenevaluatingyourcompany’s enterpriseriskmanagement(ERM). Thekeyelementsofariskmanagementprograminclude:ProcessIntegrationCultureInfrastructure. Theseelementsofariskmanagementprogramareflexible.Theyhavetobe, becausestrategies,organizationalstructures,operatingphilosophiesandriskprofilesvaryincomplexityacrossindustriesandfirms.Thisarticledescribesthestepsintheprocess—yourjobistoputthemintoactionassoonaspossible.StepOne:IdentifyRiskAnenterpriseriskassessmentprocessidentifiesandprioritizesacompany’srisks,providingqualityinputstodecisionmakerstohelpthemformulateeffectiveriskresponses,includinginformationaboutthecurrentstateofcapabilitiesaroundmanagingthepriorityrisks.Riskassessmentspanstheentireorganization,includingcriticalbusinessunitsandfunctionalareas

Simply put, a risk management plan is a document describing how your project team will monitor and respond to unexpected or uncertain events ...StartHereWhat’sNewAboutAdvertiseRequestMediaKitLoginMembersLogInHitentertosearchorESCtocloseHow-toManagingAndControlingRiskManagementTopicsWhatIs&HowToCreateARiskManagementPlanByEmilyLuijbregts29/07/2020May23rd,2021NoCommentsThePMtoolforteamsin2021Definitelycustomizable,surprisinglyintuitive.TRYFORFREEOurfriendandsupporterWhilewecanneverpredictthefuturewithanysortofcertainty,havingaclearanddetailedriskmanagementplanwillallowyoutoseeallofthepotentialoutcomesfromyourdecisionsandthenassesstheimpactofthevariousrisksthatexisttosupportyourdecision-makingduringperiodsofuncertainty.Riskmanagementplansareoftenseenasaboxtocheckbyprojectmanagersratherthanastrategicpartofyourplanningendeavors(iftheyaredoneatall!).I’veseenprojectsfailbecausetheriskmanagementplanwasnottakenseriously,orbecausetherewasn’treallyanyriskmanagementstrategybeingimplementedintheproject.WhatisaRiskManagementPlan?Simplyput,ariskmanagementplanisadocumentdescribinghowyourprojectteamwillmonitorandrespondtounexpectedoruncertaineventsthatcouldimpacttheproject.Youmayseetheterm“riskmanagementplan”shortenedto“RMP”,butithardlyhasexclusiverightstotheacronym:RMPcanalsorefertotheRiskManagementProfessionalcertificationfromPMIorResourceManagementPlaninasimilarcontext,sobemindful!Someorganizationsliketohavevast,convolutedapproachestoriskmanagement,butatitscoreriskmanagementdoesnotneedtobecomplex.Youneedtoanalyzetherisksthatexistinyourorganization/projectandthencategorizeariskresponseandresponsibleperson.What’sCoveredInARiskManagementPlan?Thefidelityofyourriskmanagementplanwillvarydependingonthenatureofyourprojectandthestandardoperatingproceduresusedbytheorganizationsinvolved.Ingeneral,ariskmanagementplanseekstoanswer:Whatisthisproject,andwhydoesitmatter?Whyisriskmanagementimportantfortheproject’ssuccess?Whatwilltheteamdotoidentify,log,assess,andmonitorrisksthroughouttheproject?Wh

ReturntoBlogHomepageHowtoCreateaRiskManagementPlanforYourProjectByScottW.O'Connor | September18,2020 IndustryAdviceManagementShareonFacebookShareonTwitterShareonLinkedinAprojectmanagerhasmanyresponsibilitieswithintheirorganization,allofwhichrevolvearoundinitiating,planning,executing,monitoring,andcontrollingprojectsthatdeliveronvariousstrategicgoals. Whileeachofthesediscretestepsintheprojectlifecycleiscriticalinitsownright,theplanningphaseisperhapsthemostimpactfulinhowitcandeterminethesuccess—orfailure—ofallofthephasesthatcomeafterit.It’sforthisreasonthatprojectmanagersareresponsibleforcreatingvariousplansfortheprojectstheyhelm.Whiletheprojectplanisoftenconsideredthemostimportantoftheseplans,itisnottheonlyone.Anumberofsubsidiaryplansarealsorecommendedand,inmanycases,required. Theriskmanagementplanisoneofthemostcrucialofthesesubsidiaryplans,asitforcestheprojectmanagertoplanforpotentialdisruptionsandopportunitiestheprojectmayencounter.Below,wedefinewhat“risk”meansintermsofprojectmanagement,takealookatwhattheriskmanagementplanactuallyis,andwalkthroughstepsyoucanfollowtocreateariskmanagementplanforyournextproject. DownloadOurFreeGuidetoAdvancingYourProjectManagementCareerLearnwhatyouneedtoknow,fromin-demandskillstotheindustry’sgrowingjobopportunities.DOWNLOADNOWWhatisprojectrisk?Whenitcomestoprojectmanagement,theterm“risk”specificallyreferstofactorsoreventswhichmightinfluencethefinaloutcomeoftheproject. Someofthemostcommonprojectrisksarethosewhichimpactaproject’sconstraints.Thisincludesthetripleconstraintofaproject’scostorbudget,itstimelineorschedule,anditsscope—allofwhichcanaffectthefinalqualityorperformanceoftheproject.Yettherearemanyotherkindsofriskthatprojectmanagersshouldbeawareof,aswell,andtheriskmanagementplanisusedtoidentifyeachofthesepotentialdisruptors. Whileriskisoftenassumedtobeanegative,itisimportanttonotethatprojectriskcanalsooccasionallybepositive,dependingonhowtheeventimpactstheproject. ForExample:Consideraprojectthatisheavilydependentuponthepriceofoil.I

A” Risk Management Plan (RMP)” is a document to assess the benefit-risk balance of a drug to prevent or minimize medication risks. TFDA introduced this ...回首頁網站導覽中文版English藥品醫療器材諮詢輔導醫療科技評估國際合作中心簡介藥品審查提供藥品技術性資料評估，以確保用藥的品質、安全與療效。

NewDrug首頁藥品審查NewDrugNewDrugRiskManagementPlanA”RiskManagementPlan(RMP)”isadocumenttoassessthebenefit-riskbalanceofadrugtopreventorminimizemedicationrisks.TFDAintroducedthisregulatoryregimebyreferencetotheadvancedcountries,suchastheUSFDAandEMA.RMPsnormallyincludemedicationguides,communicationplans,riskmitigationmeasures,etc.Itshouldberegularlymodifiedandupdatedduringthewholemedicinelifecycle.The“GuidelineontheRiskManagementPlanandtheFormat”wasissuedonApril5,2012,toassistpharmaceuticalcompaniesforpreparationofRMPandensuringfurtherrisk-minimizationmeasures.AccordingtoArticle38-1oftheRegulationsforRegistrationofMedicinalProducts,anRMPisrequiredforanapplicationofNCE(NewChemicalEntity)withnon-CPPordomesticNCE.OthernewdrugsormarketedmedicinesmayberequestedtosubmitRMPsbasedonthedrugsafetyassessmentwiththedifferentlevelsofrisk.ThefollowinginformationintroducesthesubmissionofRMPs.PleasefindmoreinformationaboutNDAsubmissionsatRulesandRegulationsorvisitthewebsitePharmaceuticalRegulationsinTaiwan.Ⅰ.CLASSIFICATIONS1.Riskmanagementplananditspost-approvalchanges2.RiskmanagementplanassessmentreportⅡ.SUBMISSIONREQUIREMENTS1.Riskmanagementplan：Acoverlettertostaterationaleforapplication,andariskmanagementplan2.Post-approvalchangesofRMP：Acoverlettertostaterationaleforapplication,thelatestapprovedRMPwiththeversionnumberanddate,anupdatedRMP,andacomparisontabletoindicatethedifferencebetweenthecurrentversionandtheproposedversionoftheRMP.3.Riskmanagementplanassessmentreport：Acoverlettertostaterationaleforapplication,thelatestapprovedRMPwiththeversionnumberanddate,andanRMPassessmentreport.III.NOTICEBEFORESUBMISSION1.Allnon-CPPNCEordomesticNCEapplicationsmusthaveanaccompanyingRMPsubmission.2.Post-approvalrevisionsoftheRMPshouldbesubmittedforassessmentandapprovalb

A risk mitigation plan is designed to eliminate or minimize the impact of the risk events—occurrences that have a negative impact on the project. Identifying risk is ...SkiptocontentMainBodyEventhemostcarefullyplannedprojectcanrunintotrouble.Nomatterhowwellyouplan,yourprojectcanalwaysencounter unexpectedproblems.Teammembersgetsickorquit,resourcesthatyouweredependingonturnouttobeunavailable,eventheweathercanthrowyouforaloop(e.g.,asnowstorm).Sodoesthatmeanthatyou’rehelplessagainstunknownproblems?No!Youcanuseriskplanningtoidentifypotentialproblemsthatcouldcausetroubleforyourproject,analyzehowlikelythey areto occur,takeactiontopreventtherisksyoucanavoid,andminimizetheonesthatyoucan’t.Ariskisanyuncertaineventorconditionthatmightaffectyourproject.Notallrisksarenegative.Someevents(likefindinganeasierwaytodoanactivity)orconditions(likelowerpricesforcertainmaterials)canhelpyourproject.Whenthishappens,wecallitanopportunity;butit’sstillhandledjustlikearisk.Therearenoguaranteesonanyproject.Eventhesimplestactivitycanturnintounexpectedproblems.Anythingthatmightoccurto changetheoutcomeofaprojectactivity,wecallthatarisk.Ariskcanbeanevent(likeasnowstorm)oritcanbeacondition(likeanimportantpartbeingunavailable).Eitherway,it’ssomethingthatmayormaynothappen…butifitdoes,thenitwillforceyoutochangethewayyouandyourteamworkontheproject.Ifyourprojectrequiresthatyoustandontheedgeofacliff,thenthere’sariskthatyoucouldfall.Ifit’sverywindyoutorifthegroundisslipperyanduneven,thenfallingismorelikely(Figure16.1).Figure16.1RiskManagementOptionsWhenyou’replanningyourproject,risksarestilluncertain:theyhaven’thappenedyet.Buteventually,someoftherisksthatyouplanfordohappen,andthat’swhenyouhavetodealwiththem.Therearefourbasicwaystohandlearisk.Avoid:Thebestthingyoucandowithariskisavoidit.Ifyoucanpreventitfromhappening,itdefinitelywon’thurtyourproject.Theeasiestwaytoavoidthisriskistowalkawayfromthecliff,butthatmaynotbeanoptiononthisproject.Mitigate:Ifyoucan’tavoidtherisk,youcanmitigateit.Thismeanstakingsomeso