dmf readiness j - · pdf filethe electronic common technical document (ectd) is...

©2017CunesoftGmbH 1

DMFRoadtoReadinessWebinar


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


TheFDAMandate

eCTDMandateTheElectronicCommonTechnicalDocument(eCTD)isCDER/CBER’sstandardformatforelectronicregulatorysubmissions.

BeginningMay5,2017submissiontypesNDA,ANDA,BLAandDrugMasterFilesmustbesubmittedineCTDformat.SubmissionsthatdonotadheretotherequirementsstatedintheeCTDGuidancewillbesubjecttorejection.

StartingMay5,2017,anynewsubmissionstoanexistingDMFmustbedoneineCTDformat.

TheDMFholdermaycontinuetousethesameDMFnumber.If theDMFholderchoosestoresubmitallofanexistingpaperDMFineCTDformat,andthereareanychangesinthecontentoftheDMFasaresultofthereformatting,theCoverLetterforthesubmissionshouldspecifywhatareasofinformationhavebeenupdated.

Updates


FDAPresentation– August2016

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM514329.pdf

Updates


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


TipsforDMFSuccessfromFDA

Besuretoapplythecorrectmetadataform3.2.pand/orm3.2.seCTDsectionsforeverysubmission.Anyminorchangewilladdanother3.2.p.and/or3.2.ssectionthus,creatingduplicatesectionsAlwaysapplythecorrecteCTDlifecycleoperator(e.g.replace)whensubmittingupdatestodocuments.Donotsubmitupdateddocumentsas“new”


ESGTips(ElectronicSubmissionsGateway)

Getanaccountearly– Accountactivationprocesscontainsmanysteps

includingsubmissionofaCDERcomplianttestsubmissionandpassingvalidation.Thismaytakemultipleattemptsandcantakeweeks.

– Instructionsarelocatedat:www.fda.gov/esgWhentransmittingtoCDER,choose“CDER”asthecenterand“eCTD”asthesubmissiontypeWhentransmittingtoCBER,choose“CBER”asthecenterand“DMF”asthesubmissiontypeQuestionsrelatedtotheGatewayshouldbedirectedto:– [email protected]


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.


Cunesoft’sUniqueValue

People Products

Process

Cunesoft’s teamiscomprisedofhighlyexperiencedprofessionalswhoknowandunderstandtheeCTDformatandthechallengesyouarefacingasyoutransitiontothisnewapproach

Cunesofthasawell-tunedprocessesforhelpingourclientsgetupandrunningwithcune-eCTD–fromfastset-up,totraining,toglobalsupport

Cunesoft’s technologyisbuiltforeaseofuse,easeofaccess,andconsistentcompliancewithregulatoryrequirements


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.


ReadinessChecklist

ReadinessChecklist


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.




Next Steps

1.Understand the



submit

3.Prepare your


4.Manage eCTD

Lifecycle

5.

Makeyourplanwellinadvance!

Checklist Description

WhattypeofDMFfilingisplanned?

TypeIItoTypeV

Documentsready? AllDocumentsavailableorpendingDocumentmanagementsystem? Documentmanagementisinplacetomaintaindocuments

andversionsSoftwareavailability? Doyouhavesoftwareoryouaregoingtooutsource

Validatoravailability? Whichvalidatortouseforcompiledoutput?ESGaccountissetup? DoyouhaveESGaccountoryouneedtostartprocessfor

settingup




Next Steps

1.

Manynewrequirements,conceptsandterminology


Areyourdocumentsready? Paperneedingtobescanned?Electronic already?FollowingCTDdocumentgranularity?

WhichCTDsectionsapplytoyourtypeofDMF DifferentDMFTypes utilizedifferentsectionsoftheeCTD

ElectronicSubmissionGatewayrequirements The FDA’sESGhasspecificrequirements

ElectronicSubmissionGatewayset-up/registration

Giveyourselfenoughtimetogetregisteredasitcansometimestakeupto30days

Understandingacknowledgements fromGateway

Know howtointerpretresponsesfromtheFDAthatarereturnedfromtheESG

Understand theeCTD &

submissionprocess


submit

3.Prepare your


4.Manage eCTD

Lifecycle

5.



FollowFDA’ssuggestions&giveyourselfplentyoftime


FollowtherecommendationsfromtheFDA Sample submissionchecklistoutlinesallpossibilitiesbutyouneedtoadaptforyourparticulartypeofDMF

EnsureyoursubmissionsareacceptedonceFDAverifiesyousamplesubmission

Formalsubmissionscannotbesentuntilsuccessfulsamplesubmissionacceptance(cantakeupto30days)


Next Steps

1.Understand the



submit

3.Prepare your


4.Manage eCTD

Lifecycle

5.



YoursuccessfultransitiontoeCTD


Organize yourdocuments Isyourmetadatacomplete?Areyourdocuments inEnglish?AreanydocumentsscannedPDFs?

Build yoursubmission&testoutput Assign documentstoproperfoldersEnsurebookmarks&hyperlinksareinplaceEnterappropriateenvelopeinformationTestoutputwithagencyvalidatorCorrecterrors

Buildyour finalsubmissionoutput Generate finaloutputandallocatesequencenumber

TransmityourfinalsubmissionthroughESG

Sendyoursubmissionto theFDA

Understandingacknowledgements fromGateway

Receiveresponse fromESGregardingacceptance


Next Steps

1.Understand the



submit

3.Prepare your


4.Manage eCTD

Lifecycle

5.



Understandyourschedule


Annual Reporting Know yourscheduleofannualreportsAmendments Onlysendneworupdatedinformation;donotresendpreviously

submittedfilesHealthauthoritycorrespondence

Ensuretimelyresponseoractionstodivisionsand/orapprovalletters

LettersofAuthorization Haveaplanforhowandwhentosubmit


Next Steps

1.Understand the



submit

3.Prepare your


4.Manage eCTD

Lifecycle

5.


Expertise Real-lifeexperience

HowCunesoftHelps

Compliance

Control

FastResponseSupport


Links

AdditionalResources:https://www.lorenz.cc/eSolutions/eValidator/

http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM514329.pdf


Your Questions


Regulatory MasterDataManagement

eCTD Submissions Regulatory DMS

Become AHappyCustomer!

Email:[email protected]:+49(0)8923514741US-Tel:+1(609)955-3468