dmf readiness j - · pdf filethe electronic common technical document (ectd) is...
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©2017CunesoftGmbH 2
Agenda
ReviewoftheFDArequirement
UniquenessofeCTDcomparedtopreviousDMF
ProductDemonstration
Readinesschecklist
Recommendedactions
Q&ASession
©2017CunesoftGmbH 3©2016CunesoftGmbH 3
„Regulatoryprocessesdoneright“
DanielKoppersCTO/Founder
!
JimNicholsVP,LifeSciencesNA
IntroducingCunesoft
Headquarters: Munich, Germany
Regional Offices: Paris, Bangalore, Princeton
Industry Focus: Regulatory Software for Life Sciences
Venture Partners: HTGF, Bayern Kapital, Occident Group
CorporateFacts GlobalLifeSciencesCustomer
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TheFDAMandate
eCTDMandateTheElectronicCommonTechnicalDocument(eCTD)isCDER/CBER’sstandardformatforelectronicregulatorysubmissions.
BeginningMay5,2017submissiontypesNDA,ANDA,BLAandDrugMasterFilesmustbesubmittedineCTDformat.SubmissionsthatdonotadheretotherequirementsstatedintheeCTDGuidancewillbesubjecttorejection.
StartingMay5,2017,anynewsubmissionstoanexistingDMFmustbedoneineCTDformat.
TheDMFholdermaycontinuetousethesameDMFnumber.If theDMFholderchoosestoresubmitallofanexistingpaperDMFineCTDformat,andthereareanychangesinthecontentoftheDMFasaresultofthereformatting,theCoverLetterforthesubmissionshouldspecifywhatareasofinformationhavebeenupdated.
Updates
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FDAPresentation– August2016
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM514329.pdf
Updates
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TipsforDMFSuccessfromFDA
PDFTableofContentsandBookmarks– Shouldbethesame– Fordocuments5pagesorlonger– Upto4levelsdeepinhierarchyOrientation– AnydocumentsprovidedinthesubmissionshouldbeinthecorrectorientationDonotincludeform356hwhensubmittingviagateway.– DMFsareautomaticallyprocessedwithouttheformScanneddocuments,includingcoverlettersshouldbeOCR’d priortosubmittingLeaftitlesofdocumentsshouldbeclearandindicativeofthedocumentCoverlettersshouldincludethesequencenumberandifpossible,dateofsubmission(e.g.coverletter-0004Oct-13-2017)Leaftitlesforallannualreportdocumentsshouldincludethereportingperiod(e.g.“AR-specifications-Oct-122016-Oct-11-2017).Thatway,reviewerscandifferentiatebetweenoneyear’sreportfromanother.Coverlettershouldhavecontactinformationforagent,ifapplicableProvideelectronicsubmissionspointofcontactfortechnicalissuesProvidecorrecttelephone,emailorfaxnumberforrejectionnotices
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TipsforDMFSuccessfromFDA
Besuretoapplythecorrectmetadataform3.2.pand/orm3.2.seCTDsectionsforeverysubmission.Anyminorchangewilladdanother3.2.p.and/or3.2.ssectionthus,creatingduplicatesectionsAlwaysapplythecorrecteCTDlifecycleoperator(e.g.replace)whensubmittingupdatestodocuments.Donotsubmitupdateddocumentsas“new”
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ESGTips(ElectronicSubmissionsGateway)
Getanaccountearly– Accountactivationprocesscontainsmanysteps
includingsubmissionofaCDERcomplianttestsubmissionandpassingvalidation.Thismaytakemultipleattemptsandcantakeweeks.
– Instructionsarelocatedat:www.fda.gov/esgWhentransmittingtoCDER,choose“CDER”asthecenterand“eCTD”asthesubmissiontypeWhentransmittingtoCBER,choose“CBER”asthecenterand“DMF”asthesubmissiontypeQuestionsrelatedtotheGatewayshouldbedirectedto:– [email protected]
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PaperDMFtoeCTDExample
WhentransitioningfrompapertoeCTDandholderisutilizingusregional.xmlv3.3DTD,themostcommonscenariosarebelow:
FirsteCTDsubmissionisanamendmenttotheDMF• Inthiscase,useasubmissiontypeoforiginalapplicationandsubmissionsubtypeof
application.UseeCTDsequencenumber=0001andSubmissionID=0001.– Subsequentamendments,includinglettersofauthorization,submittedineCTDshouldusea
submissiontypeoforiginalapplicationandsubmissionsubtypeofamendment.UsenextavailableeCTDsequencenumberandSubmissionID=0001(SubmissionIDforthefirsteCTDsubmissiontotheOriginalapplication)
FirsteCTDsubmissionisanannualreport• Inthiscase,useasubmissiontypeofannualreportandsubmissionsubtypeofreport.Use
eCTDsequencenumber=0001andSubmissionID=0001.
©2017CunesoftGmbH 11
Cunesoft’sUniqueValue
People Products
Process
Cunesoft’s teamiscomprisedofhighlyexperiencedprofessionalswhoknowandunderstandtheeCTDformatandthechallengesyouarefacingasyoutransitiontothisnewapproach
Cunesofthasawell-tunedprocessesforhelpingourclientsgetupandrunningwithcune-eCTD–fromfastset-up,totraining,toglobalsupport
Cunesoft’s technologyisbuiltforeaseofuse,easeofaccess,andconsistentcompliancewithregulatoryrequirements
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VERA– OnlineeCTDguideAutocompileeCTD’sPDF&OCRrenditionengineIncrementalpublishingValidatedaccordingtoFDAstandardseCTD4.0readyICHupgradesincluded&managedSaaS- NoinstallationneededAutomatichourlysystembackup
CunesoftSpecials
AlwayscomplianttolatestICHguidelinesImporterforeCTD’s/NeeS/CTDCreateand/orcheckhyperlinksManageeCTDlifecycleManuallycompileeCTD’sManageeCTDmetadata
MultipleusersworkinparalleleCTDviewer(delta,sequence,cumulativeandpersonalviews)SharesubmissionoutputviaportalRe-useeCTD’sacrosstheorganizationRe-usedocumentsformultipleeCTD’sPublishCTDandNeeS
AutomaticeCTDtreecreationWorkfromeCTDtemplatesCheckfornewdocumentversionsSearchasyoutypeeCTDcompliancecheckerDMSfeaturesincluded
Cunesoft– TimeSavers
GlobaleCTDManagement
cune-eCTD
cune-eCTDImportorNeweCTD’sAutoCompileCheckComplianceSubmittoGateway
TheeCTD Basics
1.
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TheRoadtoDMFReadiness
Identify YourRequirements &
Next Steps
1.Understand the
eCTD &submissionprocess
2.Prepare yoursample ESGsubmission &
submit
3.Prepare your
DMF submissionin eCTD
4.Manage eCTD
Lifecycle
5.
©2017CunesoftGmbH 17
TheRoadtoDMFReadiness
Identify YourRequirements &
Next Steps
1.Understand the
eCTD &submissionprocess
2.Prepare yoursample ESGsubmission &
submit
3.Prepare your
DMF submissionin eCTD
4.Manage eCTD
Lifecycle
5.
Makeyourplanwellinadvance!
Checklist Description
WhattypeofDMFfilingisplanned?
TypeIItoTypeV
Documentsready? AllDocumentsavailableorpendingDocumentmanagementsystem? Documentmanagementisinplacetomaintaindocuments
andversionsSoftwareavailability? Doyouhavesoftwareoryouaregoingtooutsource
Validatoravailability? Whichvalidatortouseforcompiledoutput?ESGaccountissetup? DoyouhaveESGaccountoryouneedtostartprocessfor
settingup
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TheRoadtoDMFReadiness
Identify YourRequirements &
Next Steps
1.
Manynewrequirements,conceptsandterminology
Checklist Description
Areyourdocumentsready? Paperneedingtobescanned?Electronic already?FollowingCTDdocumentgranularity?
WhichCTDsectionsapplytoyourtypeofDMF DifferentDMFTypes utilizedifferentsectionsoftheeCTD
ElectronicSubmissionGatewayrequirements The FDA’sESGhasspecificrequirements
ElectronicSubmissionGatewayset-up/registration
Giveyourselfenoughtimetogetregisteredasitcansometimestakeupto30days
Understandingacknowledgements fromGateway
Know howtointerpretresponsesfromtheFDAthatarereturnedfromtheESG
Understand theeCTD &
submissionprocess
2.Prepare yoursample ESGsubmission &
submit
3.Prepare your
DMF submissionin eCTD
4.Manage eCTD
Lifecycle
5.
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TheRoadtoDMFReadiness
FollowFDA’ssuggestions&giveyourselfplentyoftime
Checklist Description
FollowtherecommendationsfromtheFDA Sample submissionchecklistoutlinesallpossibilitiesbutyouneedtoadaptforyourparticulartypeofDMF
EnsureyoursubmissionsareacceptedonceFDAverifiesyousamplesubmission
Formalsubmissionscannotbesentuntilsuccessfulsamplesubmissionacceptance(cantakeupto30days)
Identify YourRequirements &
Next Steps
1.Understand the
eCTD &submissionprocess
2.Prepare yoursample ESGsubmission &
submit
3.Prepare your
DMF submissionin eCTD
4.Manage eCTD
Lifecycle
5.
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TheRoadtoDMFReadiness
YoursuccessfultransitiontoeCTD
Checklist Description
Organize yourdocuments Isyourmetadatacomplete?Areyourdocuments inEnglish?AreanydocumentsscannedPDFs?
Build yoursubmission&testoutput Assign documentstoproperfoldersEnsurebookmarks&hyperlinksareinplaceEnterappropriateenvelopeinformationTestoutputwithagencyvalidatorCorrecterrors
Buildyour finalsubmissionoutput Generate finaloutputandallocatesequencenumber
TransmityourfinalsubmissionthroughESG
Sendyoursubmissionto theFDA
Understandingacknowledgements fromGateway
Receiveresponse fromESGregardingacceptance
Identify YourRequirements &
Next Steps
1.Understand the
eCTD &submissionprocess
2.Prepare yoursample ESGsubmission &
submit
3.Prepare your
DMF submissionin eCTD
4.Manage eCTD
Lifecycle
5.
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TheRoadtoDMFReadiness
Understandyourschedule
Checklist Description
Annual Reporting Know yourscheduleofannualreportsAmendments Onlysendneworupdatedinformation;donotresendpreviously
submittedfilesHealthauthoritycorrespondence
Ensuretimelyresponseoractionstodivisionsand/orapprovalletters
LettersofAuthorization Haveaplanforhowandwhentosubmit
Identify YourRequirements &
Next Steps
1.Understand the
eCTD &submissionprocess
2.Prepare yoursample ESGsubmission &
submit
3.Prepare your
DMF submissionin eCTD
4.Manage eCTD
Lifecycle
5.
©2017CunesoftGmbH 22
Expertise Real-lifeexperience
HowCunesoftHelps
Compliance
Control
FastResponseSupport
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Links
AdditionalResources:https://www.lorenz.cc/eSolutions/eValidator/
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM514329.pdf
©2017CunesoftGmbH 25©2017CunesoftGmbH 25
Regulatory MasterDataManagement
eCTD Submissions Regulatory DMS
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