Preparing Compliant eCTD Submissions

Copyright 2008 e-SubmissionsSolutions.com 1

Preparing Compliant eCTD Submissions

Antoinette Azevedo, President e-SubmissionsSolutions.com

DocTrain Life Sciences, Indianapolis, IN24 June 2008


Agenda

RTF Case StudyWhat Can Go Wrong?How to Assure Compliance of Source Files?eCTD WorkflowQuestions & Discussion


Four Keys to eCTD Success

Content

Standards Technology

Process


Refuse-to-File (RTF) Case Study


The Guidance on RTF . . .

July 2006, US FDA, “Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,” Revision 1, 7087rev.pdf.


A Picture through Stock Price


Summer 2005

Small California Biotech-- Submits NDA in eCTD format to FDA CDER

eCTD publishing systemPDF toolkitElectronic document management systems

DocumentumOpenText LiveLink

ConsultantsPDF preparationeCTD publishing & QC


The Business Overview

NDA is company’s first candidate for commercializationCompany is partnered with big pharma who will assist with international sales and marketing post-approvalCompany hires 200 person sales force in anticipation of approval


Fall 2005

FDA issues Refuse to File (RTF) under PDUFA timeline

Inadequacy of individual PDF filesNavigability of content of submission

Market capitalization drops 50% overnightAnalyst conference call


Early 2006

Small biotech prepares resubmissionRework source filesRework CTD folder/file structureRebuild XML backbone

FDA accepts resubmission for review under PDUFA timeline


May 2006

FDA issues “approvable” letter under PDUFA:

Drug could be approved in future if certain conditions could be met“Conditions” to be determined in future meeting with FDA


June 2006

Big pharma company withdraws from partnership


July 2006

Small biotech lays off sales force


August 2006

Small biotech lays off more than 100 additional employees


September 2006

Small biotech has meeting with FDA concerning “approvable” conditions

Additional studies requiredAdditional analysis required


January 2007

Biotech announces plans to resubmit NDA by 2Q2007


August 2007

FDA accepts NDA for reviewFDA sets PDUFA action date of 12 December 2007


December 2007

Company Announces Sale and Leaseback of Real Estate Assets

Deal valued at $109MNet $61M after fees, expenses, etc.Leases back corporate headquarters


December 2007

FDA issues “approvable” letter under PDUFA deadline:

Objective/subjective trial in elderlyComparator safety studyPreclinical evaluation during 3rd trimester of pregnancy

Company cuts half its workforceCompany prepares meeting request to FDACeases all clinical development and pre-commercialization activities for candidate drug


January 2008

Founder-President-CEO resigns after 14 years of serviceGranted a formal meeting with FDA during 1Q08 to discuss 2007 Approvable Letter


February 2008

Hope springs eternal . . . $20.0 million upfront license fee paid for drug candidate rights for JapanBalance sheet assets of $276.7 million

10 indications Three programs in Phase 1-2 for 7 indicationsThree research programs


What Can Go Wrong with an eCTD?


FDA’s Top 12 Issues for eCTD Success*12. SPL must be in “SPL” folder

11. Use elements and leaf titles correctly

10. Always reference all files in the XML backbone(s)

9. Include Module 1 in All eCTD Submissions

8. Make sure all application numbers are 6 digits

7. Make sure all sequence numbers are 4 digits

6. Do not use node extensions

5. Verify that all MD5 checksums are correct

4. All documents should conform to eCTD granularity

3. All XML must use standard components

2. Be sure all PDF hyperlinks & bookmarks are correct

1. Include TOCs in all PDF documents

*Source: Virginia Ventura, FDA CDER Office of Business Process Support


Technical Issues with eCTD*

12. SPL must be in “SPL” folder

11. Use elements and leaf titles correctly

10. Always reference all files in the XML backbone(s)

9. Include Module 1 in All eCTD Submissions

8. Make sure all application numbers are 6 digits

7. Make sure all sequence numbers are 4 digits

6. Do not use node extensions

5. Verify that all MD5 checksums are correct

3. All XML must use standard components



Technical Issues with Source Files*

4. All documents should conform to eCTD granularity

2. Be sure all PDF hyperlinks & bookmarks are correct

1. Include TOCs in all PDF documents



What is CTD/eCTD?

Module 1Regional Info

Module 3Quality

Module 4Safety

Module 5Efficacy

2.1 Table of Contents

2.2 Introduction

2.3 Quality Overall

Summary

2.4 Nonclinical Overview

2.5 Clinical Overview

2.6 NonclinicalSummary

2.7 Clinical Summary

Module 2SummaryModule 2Summary

Module 1 Not part of CTD


What is CTD/eCTD?

Submission “nda121212”Sequence “0000” with 5 modulesSequence “0002” with 4 modules


Where is XML Required? “XML backbone”


As the FDA Sees an eCTD


Where is XML Required? Module 1 Regional


Where is XML required? Structured Product Labeling (SPL)


Where is XML required? Module 4 Study Tagging File (STF)


STF for Module 4


Where is XML required? Module 5 Study Tagging File (STF)


STF for Module 5


Potential Problems with XML

Sponsor’s hand coding of XMLeCTD publishing vendor misinterpretation of XML document type definition (DTD)Sponsor’s usage of eCTD publishing systemeCTD publishing vendor not providing enough guidance and control of user actions

http://www.sagesubmissions.com/


What is XML?

Document/data interchange standardOriginated from SGML/HTMLReplaces traditional submission table of contentsRules for individual instances contained in Document Type Definitions (DTD) or Schemas


What is XML?


Challenges of eCTD: The Numbers

According to FDA CDER:NDAs will have multiple submissions over their life-cycleOf 10 most active eNDAs:

6 had 111 to 139 submissions1 had 185 submissions1 had 202 submissions

Of eSubmissions:One initial submission had 5478 filesOne eCTD supplement had over 15,000 files


Challenges of eCTD

Document Authoring -- Creation of PDFs highly dependent on use of word processor

TemplatesStylesCross references – how & to what

Within documentOutside document


Challenges of eCTDGranularity of content organization

Module 2: Quality, Nonclinical, Clinical summariesModule 3: Quality Module 4: Nonclinical study reports Module 5: Clinical study reports

Regional differencesUS

Integrated Analysis of Safety (IAS—formerly ISS)Integrated Analysis of Efficacy (IAE—formerly ISE)

EUExpert reportsCRFs – in or outCRTs – in or out


Challenges of eCTDCollecting documents/data from study sites

Case Report FormsCost/time to convert to compliant electronic formatConsistency of organization

Changes of study protocolDifferent CROs involved in different study phasesElectronic Data Capture (EDC)Location of queries & data correction forms (DCFs)

Does my drug’s indication imply need to review CRFs?Which CRFs will I need to submit?

Deaths/Drops/Serious AEsAllOther


Challenges of eCTDDocuments/data from study sites

DataCan all the data be delivered in electronically-reviewable format?Can I convert from proprietary formats into SAS XPT compliant formats?

ExcelAccessOther

Will the agency review my electronic datasets?StabilityNonclinicalClinical


Challenges of eCTD

Electronic Document Management Systems (EDMS) vs. Shared File System

How do I know I have the final, approved document?What if the final, approved document changes?What is the effective version for a submission sequence?Do I have the time/budget/resources to implement EDMS?Will the EDMS meet the needs of my entire enterprise?Will the EDMS integrate with my e-Submission publishing process and tools?How do I assure the EDMS is 21 CRF 11 compliant?


eCTD Challenge: The Granularity

FDA CDER Study Tagging FilesScope – nonclinical & clinical study reportsLifecycle – from initial IND to product end-of-lifeSmall unit of document granularity

Hyperlinking between filesHyperlinking between submission serial numbers

A cultural change for most CROs and authors


Granularity – Quality Overall Summary


Granularity – CMC/Quality Drug Product


Study Report Granularity


US, EU, Japan Experience To Date

Problems with PDF FilesLacking navigation aids:

BookmarksHyperlinksDocument tables of contents

Absolute paths on hyperlinksSecurityFile formatIncorrect granularityReferencing proprietary style sheets


Conclusion from Experience to Date

System is needed to produce XML backboneSource documents and data need to be submission-ready & compliant with requirementsSponsors need intimate knowledge of the XML output of their commercial-off-the-shelf (COTS) systemsSponsors must understand how agencies use the components of an eCTD for review



Content


Process


How to Assure Compliance of Source Files?


Credits & Disclaimers

MS Word templates courtesy Sage Submissions LLChttp://www.sagesubmissions.com/MS Office version 2000 ProfessionalAdobe Acrobat 2007 Professionalhttp://www.adobe.com/products/acrobat/index.htmlMS Windows XP Professional 5.1 (SP2)ISIToolbox Pharma Edition 5.5.1http://www.imagesolutions.com/Default.aspx?alias=www.imagesolutions.com/isitoolbox

http://www.adobe.com/products/acrobat/index.html

http://www.imagesolutions.com/Default.aspx?alias=www.imagesolutions.com/isitoolbox

http://www.enfocus.com/product.php?id=855

http://www.enfocus.com/product.php?id=855


Credits & Disclaimers

Enfocus PitStop Professional 7.01http://www.enfocus.com/product.php?id=855eCTD sample courtesy GlobalSubmithttp://www.globalsubmit.org/Parsing/validating samples courtesy GlobalSubmit & ING Americahttp://www.ingamerica.com/

http://www.globalsubmit.org/

http://www.ingamerica.com/

http://www.fda.gov/cdrh/cesub/index.html


FDA Portable Document Format Specifications

http://www.fda.gov/cder/regulatory/ersr/PDF_specification_v11.pdfExamples follow . . .


PDF Version 1.4

Options:“Reduce file size”Output by EDMS or eCTD publishing system


Embed Fonts

Not needed for standard font setsOptions

Converting from MS WordSetting in Acrobat Distiller


Embed Fonts

OptionsEmbed from within Acrobat Standard or ProfessionalDone on a text blocksNot recommended unless no other option


Embed Fonts

OptionsEnfocus PitStop ProfessionalDone a line at a timeNot recommended unless no other option


Page Orientation


Page Size & Margins


Source of Electronic Document

Avoid scanning unless no other choiceCreate PDFs from intelligent source

MS Office—Word, Excel, PowerPointOther word processors, spreadsheets, etc.ASCII text

PDFs should be:SearchableCopy & paste to edit in other documents


If You Must Scan

Document Type Resolution

Handwritten notes 300 dpi (black ink)

Plotter output graphics 300 dpi

Photographs—b&w 600 dpi (8 bit gray scale)

Photographs—color 600 dpi (24 bit RGB)

Gels and karotypes 600 dpi (8 bit grayscale depth)

High pressure liquid chromatography 300 dpi


Lossless Image Compression for Scanned DocumentsBlack & White Image Color & GrayscaleCCITT Group 4 Fax Zip/Flate

Reduce file sizeNo loss of data



Image Color Matching

CMYK for displayPantone for printinghttp://www.pantone.com/pages/pantone/index.aspx

Calibrated lookup tables for printersPrinter application support files

Adobe Illustrator, Photoshop, IndesignMacromedia FreehandCorelDrawQuark Xpress

http://www.pantone.com/pages/pantone/index.aspx

http://www.pantone.com/pages/pantone/index.aspx



Hypertext Linking

Navigation improved for PDF documentsHypertext links for:

AnnotationsRelated sectionsReferencesAppendicesTables or figuresFor anything not located on same page


Table of Contents & Hyperlinks

Hyperlinks designated by blue text or rectangles with thin lines

Blue text for PDFs from intelligent sourceThin rectangles only option for scanned documents

Tables of ContentsHyperlinkedInvisible rectangles and blue text preferred

eCTD publishing system can automate some



Use Relative Paths for Hyperlinks

eCTD publishing system should generate automatically


Use Relative Path for Hyperlinks

However!Acrobat still shows relative path

Link report courtesy Image Solutions, Inc. ISIToolbox Pharma Edition Bookmark & Link Auditor, Export Bookmarks and Links


Bookmarks Hierarchy = TOC Up to 4 Levels



Bookmarks & Hyperlinks Magnification = Inherit Zoom

Link/Bookmark report courtesy Image Solutions, Inc. ISIToolbox Pharma Edition Export Bookmarks and Links



Page Numbering Document Page = PDF Page


Initial View = Bookmarks & Page



File Naming & Folder/File Path

Use lower cases lettersAvoid special characters except hyphensFile/folder path:

230 characters for full folder/file path64 characters for folder names

eCTD publishing system should generate/truncate automatically


Verbally Communicated Requirements

Open to TOCOptimize for Fast Web ViewFont size

12 point font for text10 point for tables (9.5 pt)


Open to TOC Page


Open to TOC


Optimize for Fast Web View


Institute Standards for Data

Inside and outside suppliersDatasets – must have complete documentation

Datasets table of contentsVariable definition file—completeDatasets in SAS transportAnnotated CRF (for human studies)


Complete Datasets Documentation


Bookmarking of CRFs



Content


Process


eCTD Workflow


eCTD Single “Document” WorkflowCollect Source

Documents & Data

Verify Completeness

Compile to Single Files or

Study Tagging Files (STF)

Release for Publishing

If incomplete,Incorrect, or

Content revisedPDF Deliverables – Individual FilesBookmarks & hyperlinksTables of contentsPagination 1 through nOptimized for fast web viewingFile Format 1.4


eCTD Submission WorkflowPrepare Repository

for HandoffInsert Content in

eCTD OutlineInsert Cross-

Document HyperlinksOutput for QC

Set Submission & Document Attributes

• Invalid XML

• Source document changed

• Dead or missing bookmarks or hyperlinks

Adjust Submission & Document Attributes

Issues?


Components of an EDMS

EDMS Server RDBMS

& File Store

Authoring Client

Rendition Server for PDF Renditions

Scanner


Components of Submission Publishing System

EDMS Server, RDBMS

& File Store

Publishing Server, & RDBMS

Publishing Client

Web Server

File Server

e-Submission

p-Submission

FDA ESG


TimeLine for ImplementationImplementation Steps 1Q 2Q 3Q 4Q 5Q 6Q

Gather EDMS & eCTD system requirements; determine validation requirements

Identify potential vendors; select short list

Prepare & issue RFP, reduce vendor list, start negotiations

Order & install hardware; install EDMS software, perform IQ/OQ validation

Train users, help desk, administrators; perform EDMS UAT & PQ validation

Install & validate eCTD software. Produce small submissions – INDs, Annual Reports, Amendments, Supplements, Safety Updates

Produce marketing application & submit


Consistency ofeCTD across ICH

Sponsors’ systemsability to managelifecycle metadataover drug’s lifetime

Vendors’ ability to offer inexpensive solutions

for multiple eCTD markets’ requirements

eCTD Critical Success Factors


eCTD: Challenges to Sponsors

Return on Investment (ROI)Cost of systems, training, process redesignCost of noncomplianceSpeed, efficiency

Submission compilationAgency review process

Lead time to application submissionOn-going compliance


eCTD: Benefits to Sponsors:

Electronic content for sponsor’s internal access(Potentially) faster agency reviewHigher quality agency reviewDemonstrated lower cost of production compared with paperFaster time from database lock to submission


Status of eCTD Requirements

FDA CDEReCTD mandated January 1, 2008+ for electronic submissions

CBERAccepting both eCTD and eBLASometimes e-submission mandatory (fast-track, rolling submissions)

FDA CDRHGuidances requiredInformal pilots underwayTurbo 510K http://www.fda.gov/cdrh/cesub/index.htmlGlobal Harmonization Task Force (GHTF) and STED

http://www.e-submissionssolutions.com/


Status of FDA ESG

e-Sub May 2006 May 2007 Feb 2008 Total

AERS 9,109 12,917 247,925

CDER 20 1,009 15,931

CBER 6 101 2,146

CDRH 153 75 3,364

CVM 414

Totals 9,228 14,201 269,780


Business Case for ESG

1500 submissions (non-AERS)Manual submission of electronic media & supporting paper = $111,183ESG startup (training, security certificates, hardware) = $30,999 . . . $20.00+

Time/resource efficiency for Sponsor & Agency


Business Case Against Paper

10 copies, 100 volume submission$163,290 Total

$147,000 = printing$5,790.00 = binder materials$10,500.00 = shipping

Does not include labor to assemble, page stamp, manual TOCs, binding, QC, labeling, packing



Content


Process


Status of eCTD Requirements

EU/Japan/CanadaPDF reviewers’ aids accepted along with paper volumeseCTD dependent on each country’s information technology infrastructureNeeds early & frequent communication to determine ability to accept & review

Rest of WorldHighly dependent on information technology infrastructure to review e-submissions


EMEA eCTD Statement of Intent

1 July 2008 – accept eCTD or non-eCTD electronic-only1 January 2009 – strongly recommend eCTD or non-eCTD; paper an exception1 July 2009 – strongly recommend eCTD; paper and other formats an exception

All applications (new and existing)All submission types for Centralised ProcedureRapporteurs & CHMP members receive no paper or other electronic formats beyond this date


Japan eCTD Experience

MHLW statistics as of December 2007:Original Applications = 6 (13 sequences)Reference Applications = 52 (70 sequences)Total = 58 (83 sequences)

Free eCTD ValidatorIntegrating eClinical Trial and eSubmissionthroughout drug development lifecycle

CDISC standars for clinical trial data


Health Canada eCTD Transition

Phase 1 – Co-submissionOriginal Submission: eCTD Format on CD and DVD along with full paper-based submission in CTD formatSubsequent Submissions: Continue use of both formats

Phase 2 - Hybrid submissionOriginal Submission: eCTD format on CD and DVD along with Module 1 and 2 only in paper-based CTD formatSubsequent submissions: Submit Modules 1 & 2 in both formatsOriginal & Subsequent Submissions: Modules 3 to 5 may be subjectto print-on-demand requests

Electronic-only Original Submission: eCTD format with no accompanying paperSubsequent submissions: Do not revert to paper-based CTD


Health Canada: Criteria for Participation in the Hybrid Filing Format Pilot

Guidance Comparison

January 25, 2006(for pilot beginning on June 30, 2006)

December 31, 2007(effective immediately)

Candidate submission types

Submission has priority review statusSubmission qualifies under the Notice of Compliance with conditions (NOC/c) policyHealth Canada does not have capacity or ability to perform electronic reviewSubmission to be assigned to a reviewer on contract or a teleworker

New Drug Submissions (NDSs), Abbreviated New Drug Submission (ANDS), Supplement to a New Drug Submission (SNDS), Supplement to a Abbreviated New Drug Submission (SANDS)NDS labeling only if the original submission was filed in the co-submission or hybrid filing formatsNotifiable Change submissions and annual updates of Notices of Change related to a previously filed eCTD submission that was filed in the hybrid filing format


Health Canada: Criteria for Participation in the Hybrid Filing Format Pilot

Guidance Comparison

January 25, 2006(for pilot beginning on June 30, 2006)

December 31, 2007(effective immediately)

Conditions where candidate will not be considered

Submission has Priority Review statusSubmission qualifies under the Notice of Compliance with conditions (NOC/c) policyHealth Canada does not have the capacity and ability to perform an electronic reviewSubmission to be assigned to a reviewer on contract or a teleworker

Health Canada does not have the capacity and ability to perform an electronic reviewSubmission to be assigned to a reviewer on contract


Health Canada: Implementation Considerations

Issue Co-Submission (Guidance Section 6.1)

Hybrid Submission (Guidance Section 6.2)

Electronic-only Submission (Guidance Section 6.3)

Paper content Complete paper-based CTD format

Modules 1 & 2 in paper No paper

Legal record Paper-based submission eCTD submission eCTD submission

Signature Wet ink signature required

Digitized or scanned copy of signed document

Electronic signature

Letter of Attestation

Stating that material in eCTD format exactly matches material in CTD

Stating Modules 1 & 2 in eCTD format exactly matches material in CTD

Not applicable

Technical pre- submission consultation

Recommended Required To be determined

Print on demand

Not applicable <500 pages – done by Health Canada>500 pages – done by

sponsor on request

To be determined


FDA Status--Part 15 Hearing

Request for public input to influence development of new policy/regulation

What do you think about an all-electronic submission environment?What do you think about implementing an electronic platform to promote electronic sharing and exchange of research and regulatory information?

Public rule being written to mandate electronic submissions across all Centers of FDA—”years” to reach final ruleRFI issued for public-private partnership to implement all-electronic submission environmenthttp://www.fbo.gov/spg/HHS/FDA/DCASC/e-Platform-RFI/listing.html

http://www.zorchsoftware.com/solutions.htm


FDA Datasets Status -- Study Data Tabulation Model (SDTM)

FDA Public Meeting February 1, 2005http://www.fda.gov/oc/datacouncil/presentations.htmlSteps being taken by FDA to require submission in electronic format:

Stability datasets – HL7Animal datasets – tabulation & analysis-readyHuman datasets – tabulation & analysis-ready

Profound change from business as usualAgencySponsorsCROsVendors

Additional resources:http://www.cdisc.org/http://www.hl7.org/

http://www.cdisc.org/

http://www.hl7.org/

http://pim.emea.europa.eu/


FDA Status—Electronic Submission Gateway (ESG)

May 2006 – implemented Electronic Submission Gateway to enable fully-electronic bidirectional communicationhttp://www.fda.gov/esg/If sponsor has electronic signature policy & technology in place, no paper is required with submissions

Forms (1571, 356h) and documents which require original wet signature on hardcopyAcceptable formats

Scanned signaturesDigital signaturesFlattened digital signatures

http://www.fda.gov/cder/regulatory/ersr/PDF_specification_v11.pdf


FDA Status--RPS

Regulated Product Submission (RPS) under development

Create one model for submission of regulated product information

Framework for sponsors to send regulatory informationReviewers able to consistently locate requisite content

Animal and human products—human therapeutics, medical devices, food additives, veterinaryWorldwide use


FDA Status--RPS

Development under HL7Randy Levin of FDA CDER one of three Co-ChairsHL7 being recognized as standards body by ICH

StatusJune 2005 RPS Project initiatedSept. 2006 first test submission to FDA2010+ implemented as extension to eCTD


RPS--More Information

RCRIM’s TC: https://www.hl7.org/Special/committees/rcrim/index.cfmRPS Information Pagehttps://gforge.nci.nih.gov/plugins/wiki/index.php?Regulated%20Product%20Submission&id=234&type=gHL7 toolshttps://www.hl7.org/Library/data-model/V3Tooling/toolsIndex.htm

http://www.mastercontrol.com/solutions/pharm/document_control_fb.html

http://www.emc.com/dsp/DisplayProducts

http://www.emc.com/dsp/DisplayProducts

http://www.globalsubmit.org/gs_review.html

http://www.globalsubmit.org/gs_review.html


FDA—SPL Resources

Providing Regulatory Submissions in Electronic Format – Content of Labelinghttp://www.fda.gov/cder/guidance/6719fnl.pdf

SPL Standard for Content of LabelingQ&Ashttp://www.fda.gov/cder/guidance/7074fnl.pdf

FDA proposes to perform Indexing of SPL:http://www.fda.gov/cder/guidance/7662dft.pdf

http://www.cdisc.org/

http://www.nihs.go.jp/dig/ich/m2index-e.html

http://www.imagesolutions.com/Default.aspx?tabid=71


FDA Data Standards Council

http://www.fda.gov/oc/datacouncil/Structured Product Labeling

Drug RegistrationDrug Listing

Regulated Product SubmissionCDISC Data StandardsStability Data Standards

http://www.fda.gov/oc/datacouncil/


FDA Resources for CTD

Regulatory Submissions in Electronic Format –General Considerationshttp://www.fda.gov/cder/guidance/4156dft.pdf

eCTD Backbone Files Specification for Module 1http://www.fda.gov/cder/regulatory/ersr/Module1Spec.pdf

eCTD Backbone Files Specification for Modules 2 through 5http://www.fda.gov/cder/regulatory/ersr/module2-5spec.pdf

http://www.liquent.com/solutions/insight-publisher.asp

http://medxview.com/products/ectd/composer.htm

http://medxview.com/products/ectd/auditor.htm



eCTD Backbone Files Specification for Study Tagging Files (STF)--Module 4 & Module 5http://www.fda.gov/cder/regulatory/ersr/FDA%20implementation%20of%20STFv2-6.pdf

Comprehensive Table of Contents Headings and Hierarchyhttp://www.fda.gov/cder/regulatory/ersr/5640CTOC-v1.2.pdf

http://www.pipelineedm.com/

http://www.pipelineedm.com/

http://www.omniciainc.com/products/bundled.htm

http://www.omniciainc.com/products/bundled.htm



Study Data Specifications--Datasetshttp://www.fda.gov/cder/regulatory/ersr/Studydata-v1.3.pdf

Portable Document Format Specificationshttp://www.fda.gov/cder/regulatory/ersr/PDF_specification_v11.pdf

http://www.oneclinical.com/ATeCTDManagement.asp

http://www.oneclinical.com/ATeCTDManagement.asp

http://www.fda.gov/oc/datacouncil/presentations.html


Summary

EU & Japan & Canada – eCTD preferred format for electronic; CTD required format for paperUS – CTD preferred format for paper Rest of World-- ability to accept & review varies widelyeCTD preferred format for e-Submissions eCTD remains optional except FDA CDER Paper submissions required by most countries

Agency cannot legally accept electronic-onlyAgency IT infrastructure inadequate to perform electronic review


eCTD Success! Critical Success Factors:Faster time to marketHappier stockholdersGreater employee & management satisfactionLower cost of productionSimultaneous global submissionsHealthier patients


Questions & Discussion

Antoinette Azevedo, President & CEOe-SubmissionsSolutions.com

[email protected]://www.e-SubmissionsSolutions.com/

Telephone (619) 220-7081Fax (619) 220-0831

mailto:[email protected]

http://www.e-submissionssolutions.com/

Economy & Finance

Preparing Compliant eCTD Submissions