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Road to DMF Readiness 2.0 - 2018 update
- 1. © 2018 Cunesoft GmbH 1 DMF Road to Readiness 2.0 2018 Update
- 2. © 2018 Cunesoft GmbH 3 Agenda Review of the FDA requirement Uniqueness of eCTD compared to previous DMF Product Demonstration Readiness checklist Recommended actions Q&A Session Special Announcement Cunesoft Cunesoft Announcement One attendee will win a free 6-month cune-eCTD software subscription PLUS A special announcement for all attendees
- 3. © 2018 Cunesoft GmbH 4 Today´s Speakers Jim Cunesoft Introduction Donna Stay Tuned!
- 4. © 2018 Cunesoft GmbH 5© 2018 Cunesoft GmbH 5 Headquarters: Munich, Germany Regional Offices: Paris, Bangalore, Princeton Industry Focus: Regulatory Software for Life Sciences Venture Partners: HTGF, Bayern Kapital, Occident Group Rainer Schwarz Founder and CEO Daniel Koppers Founder and CTO Jim Nichols COO Global Life Sciences Customer Cunesoft Introduction Corporate Facts
- 5. © 2018 Cunesoft GmbH 6 Poll 2-3 Minutes
- 6. © 2018 Cunesoft GmbH 7 FDA Mandate eCTD Mandate The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. Beginning May 5, 2017, submission types NDA, ANDA, BLA became required to be submitted in eCTD format. Submissions that do not adhere to the requirements stated in the eCTD Guidance will be subject to rejection. Starting May 5, 2018, submission types IND and DMF must be submitted in eCTD format – including any new submissions to an existing DMF. The DMF holder will continue to use the same DMF number. If the DMF holder chooses to resubmit all of an existing paper DMF in eCTD format, and there are any changes in the content of the DMF as a result of the reformatting, the Cover Letter for the submission should specify what areas of information have been updated. You should first consult with FDA regarding complete resubmissions Updates
- 7. © 2018 Cunesoft GmbH 8 FDA Presentation August 2016 http://www.fda.gov/downloads/Drugs/De velopmentApprovalProcess/SmallBusiness Assistance/UCM514329.pdf Updates
- 8. © 2018 Cunesoft GmbH 9 Tips for DMF Success from FDA PDF Table of Contents and Bookmarks – Should be the same – For documents 5 pages or longer – Up to 4 levels deep in hierarchy Orientation – Any documents provided in the submission should be in the correct orientation Do not include form 356h when submitting via gateway. – DMFs are automatically processed without the form Scanned documents, including cover letters should be OCR’d prior to submitting Leaf titles of documents should be clear and indicative of the document Cover letters should include the sequence number and if possible, date of submission (e.g. coverletter-0004Oct-13-2018) Leaf titles for all annual report documents should include the reporting period (e.g. “AR- specifications-Oct-122016-Oct-11-2018). That way, reviewers can differentiate between one year’s report from another. Cover letter should have contact information for agent, if applicable Provide electronic submissions point of contact for technical issues Provide correct telephone, email or fax number for rejection notices
- 9. © 2018 Cunesoft GmbH 10 Tips for DMF Success from FDA Be sure to apply the correct metadata for m3.2.p and/or m3.2.s eCTD sections for every submission. Any minor change will add another 3.2.p. and/or 3.2.s section thus, creating duplicate sections Always apply the correct eCTD life cycle operator (e.g. replace) when submitting updates to documents. Do not submit updated documents as “new”
- 10. © 2018 Cunesoft GmbH 11 ESG Tips (Electronic Submissions Gateway) Get an account early – Account activation process contains many steps including submission of a CDER compliant test submission and passing validation. This may take multiple attempts and can take weeks. – Instructions are located at: www.fda.gov/esg When transmitting to CDER, choose “CDER” as the center and “eCTD” as the submission type When transmitting to CBER, choose “CBER” as the center and “DMF” as the submission type Questions related to the Gateway should be directed to: – ESGHELPDESK@fda.hhs.gov
- 11. © 2018 Cunesoft GmbH 12 Paper DMF to eCTD Example When transitioning from paper to eCTD and holder is utilizing usregional.xml v3.3DTD, the most common scenarios are below: First eCTD submission is an amendment to the DMF • In this case, use a submission type of original application and submission subtype of application. Use eCTD sequence number = 0001 and Submission ID = 0001. – Subsequent amendments, including letters of authorization, submitted in eCTD should use a submission type of original application and submission subtype of amendment. Use next available eCTD sequence number and Submission ID = 0001 (Submission ID for the first eCTD submission to the Original application) First eCTD submission is an annual report • In this case, use a submission type of annual report and submission subtype of report. Use eCTD sequence number = 0001 and Submission ID = 0001.
- 12. © 2018 Cunesoft GmbH 13 Cunesoft’s Unique Value People Products Process Cunesoft’s team is comprised of highly experienced professionals who know and understand the eCTD format and the challenges you are facing as you transition to this new approach Cunesoft has a well-tuned processes for helping our clients get up and running with cune-eCTD – from fast set-up, to training, to global support Cunesoft’s technology is built for ease of use, ease of access, and consistent compliance with regulatory requirements
- 13. © 2018 Cunesoft GmbH 14© 2018 Cunesoft GmbH 14 VERA – Online eCTD guide Auto compile eCTD’s PDF & OCR rendition engine Incremental publishing Validated according to FDA standards eCTD 4.0 ready ICH upgrades included & managed SaaS - No installation needed Automatic hourly system backup Cunesoft Specials Always compliant to latest ICH guidelines Importer for eCTD’s/NeeS/CTD Create and/or check hyperlinks Manage eCTD lifecycle Manually compile eCTD’s Manage eCTD meta data Multiple users work in parallel eCTD viewer (delta, sequence, cumulative) Share submission output via portal Re-use eCTD’s across the organization Re-use documents for multiple eCTD’s Also publish CTD and NeeS Automatic eCTD tree creation Work from eCTD templates Check for new document versions Search as you type eCTD compliance checker DMS features included Cunesoft – Time Savers Global eCTD Management cune-eCTD Overview Import or New eCTD’s Auto Compile Check Compliance Submit to Gateway The eCTD Basics 1. cune-eCTD
- 14. © 2018 Cunesoft GmbH 15 cune-eCTD
- 15. © 2018 Cunesoft GmbH 16 Readiness Checklist Readiness Checklist
- 16. © 2018 Cunesoft GmbH 17 The Road to DMF Readiness 2.0 Identify Your Requirements & Next Steps 1. Understand the eCTD & submission process 2. Prepare your sample ESG submission & submit 3. Prepare your DMF submission in eCTD 4. Manage eCTD Lifecycle 5.
- 17. © 2018 Cunesoft GmbH 18 Identify Your Requirements & Next Steps 1. Understand the eCTD & submission process 2. Prepare your sample ESG submission & submit 3. Prepare your DMF submission in eCTD 4. Manage eCTD Lifecycle 5. Make your plan well in advance! Checklist Description What type of DMF filing is planned? Type II to Type V Documents ready? All Documents available or pending Document management system? Document management is in place to maintain documents and versions Software availability? Do you have software or you are going to outsource Validator availability? Which validator to use for compiled output? ESG account is setup? Do you have ESG account or you need to start process for setting up The Road to DMF Readiness 2.0
- 18. © 2018 Cunesoft GmbH 19 Identify Your Requirements & Next Steps 1. Many new requirements, concepts and terminology Checklist Description Are your documents ready? Paper needing to be scanned? Electronic already? Following CTD document granularity? Which CTD sections apply to your type of DMF Different DMF Types utilize different sections of the eCTD Electronic Submission Gateway requirements The FDA’s ESG has specific requirements Electronic Submission Gateway set- up/registration Give yourself enough time to get registered as it can sometimes take up to 30 days Understanding acknowledgements from Gateway Know how to interpret responses from the FDA that are returned from the ESG Understand the eCTD & submission process 2. Prepare your sample ESG submission & submit 3. Prepare your DMF submission in eCTD 4. Manage eCTD Lifecycle 5. The Road to DMF Readiness 2.0
- 19. © 2018 Cunesoft GmbH 20 Follow FDA’s suggestions & give yourself plenty of time Checklist Description Follow the recommendations from the FDA Sample submission checklist outlines all possibilities but you need to adapt for your particular type of DMF Ensure your submissions are accepted once FDA verifies you sample submission Formal submissions cannot be sent until successful sample submission acceptance (can take up to 30 days) Identify Your Requirements & Next Steps 1. Understand the eCTD & submission process 2. Prepare your sample ESG submission & submit 3. Prepare your DMF submission in eCTD 4. Manage eCTD Lifecycle 5. The Road to DMF Readiness 2.0
- 20. © 2018 Cunesoft GmbH 21 Your successful transition to eCTD Checklist Description Organize your documents Is your metadata complete? Are your documents in English? Are any documents scanned PDFs? Build your submission & test output Assign documents to proper folders Ensure bookmarks & hyperlinks are in place Enter appropriate envelope information Test output with agency validator Correct errors Build your final submission output Generate final output and allocate sequence number Transmit your final submission through ESG Send your submission to the FDA Understanding acknowledgements from Gateway Receive response from ESG regarding acceptance Identify Your Requirements & Next Steps 1. Understand the eCTD & submission process 2. Prepare your sample ESG submission & submit 3. Prepare your DMF submission in eCTD 4. Manage eCTD Lifecycle 5. The Road to DMF Readiness 2.0
- 21. © 2018 Cunesoft GmbH 22 Understand your schedule Checklist Description Annual Reporting Know your schedule of annual reports Amendments Only send new or updated information; do not resend previously submitted files Health authority correspondence Ensure timely response or actions to divisions and/ or approval letters Letters of Authorization Have a plan for how and when to submit Identify Your Requirements & Next Steps 1. Understand the eCTD & submission process 2. Prepare your sample ESG submission & submit 3. Prepare your DMF submission in eCTD 4. Manage eCTD Lifecycle 5. The Road to DMF Readiness 2.0
- 22. © 2018 Cunesoft GmbH 23 Real Life Experience Donna Whiting Donna Coming Soon!
- 23. © 2018 Cunesoft GmbH 24 Authoring and managing “submission ready” documents, as well as compiling, publishing, validating, submitting and maintaining eCTD submissions takes practice and a well-structured process in order to be successful. At Cunesoft, we find that over 70% of our support calls are NOT related to the technology, but rather, they are almost always related to regulatory details. Many customers view eCTD just as a regulatory requirement, rather than an opportunity to streamline processes and procedures. eCTD Means A New Way of Working
- 24. © 2018 Cunesoft GmbH 25 Understand ICH and regional eCTD terminologies and requirements, and how they will impact your documents and submissions – How do I need to break up older, large documents into smaller documents (granules)? – Where will each document map into the eCTD structure? – What is a submission vs. a sequence? – What is lifecycle management (ie, each activity is NOT a new submission, but rather a new sequence)? – Why can’t I just delete a sequence or a document? – What is metadata? – What metadata is associated with the product? – What metadata is associated with the document? – What is a study tagging file or node extension and why do I need them? – Is what my organization creates a product or a substance? Before transitioning to eCTD 1 of 4
- 25. © 2018 Cunesoft GmbH 26 2 of 4 Author and create documents that are “Submission Ready,” minimizing rework: – Follow ICH and regional requirements for document granularity for easy re-use – Follow ICH and regional requirements for file naming conventions (eg, FDA’s Comprehensive Table of Contents Headings and Hierarchy document) – Utilize templates to author MS Word documents and ensure consistency in format across the contents of your submission – Utilize MS Word heading styles for automatic creation of bookmarks on rendering – Create MS Word document Tables of Contents (for documents 5 pages or more) – Provide bookmarks and hyperlinks as required – Render files in PDF version 1.x or higher – Scanned documents must be text searchable (OCR) Before transitioning to eCTD
- 26. © 2018 Cunesoft GmbH 27 3 of 4 Understand how transitioning to eCTD may impact your organization – Roles and responsibilities • Who will create Product Containers, Documents or Submissions? • Will one or multiple functions publish? – If various groups publish, how will sequence numbers and tracking tables (for EU/Canada) for a product be managed? (Example: one function could be working on an NDA for a product, the Labeling group could be working on an SPL submission for the same product, and another group could be submitting an Adverse Event or promotional submission for the same product – all in eCTD format.) – Will there be an impact on headcount/resources? – Do you have senior executive support that encourages user acceptance? – Do you have the authority to implement new or updated international procedures, standard operating procedures and/or work instructions? – Will you establish a change management processes? Before transitioning to eCTD
- 27. © 2018 Cunesoft GmbH 28 4 of 4 Consider what other tools you might need – A validation tool – Access to a Health Authority gateway or portal (may take time to obtain) – A tool to zip/unzip files Will you have a defined support model – both business and IT? – Don’t underestimate the value of good training and support. – New or updated Support documentation – Which role (business or IT) interacts with the tool provider (to ensure bugs are fixed, feature requests are prioritized)? Did you plan for user and IT training, training materials? Before transitioning to eCTD
- 28. © 2018 Cunesoft GmbH 29 Your Product in cune-RDMS – Think of your Product Container as the File Cabinet that stores all the documents for your Product over its lifetime. Organization of the Product Container is important, as over time the number of files to manage for the product will increase. – Will your product be submitted to one or several markets over time? – Will you use Folders and Subfolders to help you organize your files? Understanding Product and Document Metadata and how they impact the eCTD Submission Structure – Metadata from your Product drives eCTD folder creation • Product name, Product manufacturer • Substances, Substance manufacturers • Dosage forms Things to consider
- 29. © 2018 Cunesoft GmbH 30 Give your product container a logical name If submitting to one market only, this might be your product name, product description, or application number: • DMF 012345 • Drug XYZ • Resins If submitting to more than one market, this might be your product name or product description: • Resins • Colorants • Drug XYZ You can use as many or as few folders as you want to organize the files within your product container. Note: You cannot have two files or two folders with the same name in the same product container. The name of your Product Container does not impact the name of your eCTD, but it will drive folders in Module 3.2.P Drug Product. One Product Container can be associated with multiple eCTDs. However, one eCTD, can only be associated with one Product Container. DMF 123456 1.2 Cover Letter 02Jan18 1.3.1.1 Change of Name or Corp AddressM1 2.3 QOS M2 3.2.S.1.1 NomenclatureM3 1.13.5 Summary of Mfg Changes Colorants 1.2 Cover Letter 02Jan18 1.3.1.1 Change of Name or Corp AddressM1 US 2.3 QOSM2 3.2.S.1.1 NomenclatureM3 1.13.5 Summary of Mfg Changes M1 EU 1.0 Cover Letter 08Jan17 Tips for setting up the RDMS Structure Product Container Folders within Product Container Documents
- 30. © 2018 Cunesoft GmbH 31 002256 (ie DMF #) Sequence 0001 Cover Letter LOA Sequence 0002 Cover Letter LOA Your first submission is about your overall DMF Your SUBMISSION equals your DMF # (aka Application #) The SEQUENCE is about its purpose The CONTENT communicates the documents Your NEXT regulatory activity is the NEXT SEQUENCE Not a ‘new submission’ Example: DMF Submissions in eCTD Submission Sequence Content
- 31. © 2018 Cunesoft GmbH 32 Expertise Real-life experience How Cunesoft Helps Compliance Control Fast ResponseSupport
- 32. © 2018 Cunesoft GmbH 33 Links Additional Resources: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ http://www.fda.gov/downloads/Drugs/DevelopmentApprovalPro cess/SmallBusinessAssistance/UCM514329.pdf Almost there!
- 33. © 2018 Cunesoft GmbH 35 Cunesoft Announcement Cunesoft Announcement 1. Win a free 6-month cune-eCTD software license 2. Special announcement for all attendees
- 34. © 2018 Cunesoft GmbH 36 Cunesoft Announcement And the Winner of the cune-eCTD License is… Import or New eCTD’s Auto Compile Check Compliance Submit to Gateway Build to Submit DMF
- 35. © 2018 Cunesoft GmbH 37 Cunesoft Announcement Special Announcement cune-eCTD Import or New eCTD’s Auto Compile Check Compliance Submit to Gateway Build to Submit DMF
- 36. © 2018 Cunesoft GmbH 38 Cunesoft Announcement Special Announcement cune-eCTD Import or New eCTD’s Auto Compile Check Compliance Submit to Gateway Build to Submit DMF
- 37. © 2018 Cunesoft GmbH 39 Cunesoft Announcement Special Announcement cune-eCTD Import or New eCTD’s Auto Compile Check Compliance Submit to Gateway Build to Submit DMF
- 38. © 2018 Cunesoft GmbH 40 Poll 2-3 Minutes
- 39. © 2018 Cunesoft GmbH 41 Your Questions
- 40. © 2018 Cunesoft GmbH 42© 2018 Cunesoft GmbH 42 Cunesoft Email: info@cunesoft.com Tel: +49 (0)89 235 14 741 eCTD Submissions Regulatory DMS Become a happy customer ! Data Lifecycle Management SOP Managment Regulatory Master Data Management Contact us
Editor's Notes
- Good day everybody! My name is Jim Nichols and I’d like to welcome you to Cunesoft’s webinar about a journey many of you are about to take – a journey on the road to DMF readiness.
- Along the DMF road to readiness, we will discuss several key points along the way. First we will review the FDA mandate that has brought us all here, we’ll then talk about what makes the eCTD format unique and different from your traditional DMF submissions and then we’ll have a product demonstration of cune-eCTD. Following the demonstration, we’ll share with you a comprehensive readiness checklist that you can use as a guide on your own journey followed by our recommended next steps. Finally, we’ll wrap up with a Q&A session. Overall, this session will last about 45 minutes and we certainly hope that you will find the information useful as you consider your plans for eCTD submission compliance in a few months.
- Along the DMF road to readiness, we will discuss several key points along the way. First we will review the FDA mandate that has brought us all here, we’ll then talk about what makes the eCTD format unique and different from your traditional DMF submissions and then we’ll have a product demonstration of cune-eCTD. Following the demonstration, we’ll share with you a comprehensive readiness checklist that you can use as a guide on your own journey followed by our recommended next steps. Finally, we’ll wrap up with a Q&A session. Overall, this session will last about 45 minutes and we certainly hope that you will find the information useful as you consider your plans for eCTD submission compliance in a few months.
- Before we get started, we do have a quick poll that we’d like to share with you. Basically, we would like to know which of our topics has brought you here to our webinar today. You’ll see the poll question on your screen and you can simply click on your response. AFTER POLL: I want to thank all of you for sharing your opinion here today. I certainly hope that we meet your expectations and should you have any questions, please remember that we will have a q&a session at the end of the webinar today.,
- So why are we on this journey? Well, it basically comes down to a mandate handed down by the FDA stating that as of May 5 2018 – less than 3 months from today – all submission types must be in eCTD format. As you can see, this goes well beyond typical new drug applications, but specifically includes Drug Master File submissions. What’s more, if companies don’t adhere to this, their submissions will be subject to rejection. As for DMFs specifically, there is some further guidance: you will use your existing DMF number as the application number (you may need to add a zero in the front of the number to make sure it is 6 digits long). With regard to FDA, you are NOT required to resubmit all of the materials of your existing DMF but, IF you do choose to do so, you can… and you just need to be clear in your cover letter regarding which information may have also been updated since the original submission.
- And to further reinforce the reality of this, we have included just a few pieces of an FDA webinar from August of last year. Here you see the reinforcement of the eCTD requirement as well as their position on waivers and exemptions… and that position is that there are no waivers or exemptions as many had hoped there may be. We have also included the URL to this entire presentation in case you’d like to see it in its entirety.
- There are some key suggestions, tips and guidance included in several different documents available from the FDA. What we have done here and in the next few slides is summarize them to give you an idea of the types of things you will want to be thinking about and paying attention to. Starting with your documents, there are requirements about how tables of contents and the bookmarks in your PDFs should appear, about page orientation, and how to handle documents created via scanning. With eCTD, considering and planning the names of your leaf titles is important as they should be clear and indicative of the nature of the document. And here, I’ll stop and point out that you’ll hear new terms like ‘Leaf’ and ‘Backbone’. In the world of eCTD, a ‘Leaf’ is essentially one PDF document in your eCTD submission. The ‘Backbone’ or ‘XML Backbone’ as it’s sometimes called, is a file that essentially helps organize these Leaf files in a structure and with the context of how they’re being provided in the submission. One thing you don’t need to worry about is this Backbone file… an eCTD technology like cune-eCTD is designed specifically to handle this for you and will get created automatically. And because we’re talking about a process that not only produces your submission in electronic format, but one that also involves sending it electronically, there are additional (and potentially new) pieces of information you need to consider. Information such as different contacts and contact information will need to be provided in the submission in case the FDA needs to reach out to you about possible questions.
- Now, some more tips may sound even more ominous because we start hearing the words ‘metadata’ and ‘lifcycle’. Not to worry but I will explain these briefly The metadata is basically the attributes you will be associating with different sections of your submission. Things like product name and manufacturer are pieces of information that will help to have the correct folders created for your submission. The term ‘lifecycle’ really pertains to one of the most important concepts of the eCTD. You’ll remember I mentioned that Backbone file earlier… in that file, for each Leaf that is getting submitted, there is an attribute referred to as the lifecycle operator. This is an indicator to the receiving agency’s system about each of those Leaf files: NEW meaning that this is a Leaf that’s being submitted for the first time, REPLACE meaning that this Leaf is replacing a previously submitted Leaf, and so on. Again, these should be things you worry too much about if you’re using something like cune-eCTD because the solution takes care of these things for you and makes it very easy for you to understand.
- Now I mentioned before that not only are you creating an electronic submission, but you’ll also be sending it to the FDA electronically. This will be done by using the FDA’s electronic submission gateway or ESG. There are several tips here as well. The biggest and most important tip is that you should sign up for your account as soon as possible. The reason being that things operate on a first come/first served basis and for some of the steps I this process, the FDA has set the expectation that their responses may take as long as 4 weeks. Now, when we’re less than 3 months away from that key date in May, 4 weeks can fly by very quickly.
- Now here we get into some pretty specific details about how to fill out your submission envelope information. You will see two scenarios here: one in the event that your first eCTD is an amendment to a DMF, and the other for the case where your first eCTD is an annual report for your DMF. Again, solutions like cune-eCTD will guide you through filling out your submission envelope as you create your eCTD.
- So, if all of this has you worried, don’t be! Why? Because by working with Cunesoft, you can rest assured that we have the People, Products and Process to help you on your road to DMF submissions. Cunesoft’s people are experts and experienced. We know the eCTD and we know the challenges you’re facing. Cunesot’s products are purpose-built for these requirements. They’re easy to use and always compliant with regulatory requirements. And Cunesoft’s processes are tried and proven. From getting your system set up, to providing live training, and to having a support team operating in North America, Europe and India Combined, we firmly believe this gives Cunesoft a unique value to you and our customers.
- Next I’d like to talk about our DMF Readiness Checklist. I’ll step through the key 5 steps of the checklist in a moment but would also like to let everybody know that you can also download this checklist from our website.
- As I mentioned, there are 5 key steps to ensure you’re ready for submitting your DMFs as eCTDs: Identifying your requirements and next steps, understanding the eCTD and the submission process, preparing your sample submission for the electronic submissions gateway (or ESG) and submitting it, creating your actual DMF submission, and finally managing your DMF’s lifecycle in eCTD I’ll review each of these steps in a bit more detail…
- Some of the key things to consider in this first step is your plan. You should understand the types of DMFs you’ll be preparing, assessing your documents in terms of format (are they in Word, PDF, paper) and if you’re using a document management system, is it properly organized. Obviously, knowing if your company may already have software to handle these submissions would be useful but also thinking about if you plan to handle these eCTD submissions in-house or if you’ve thought about outsourcing them. And next, do you know which eCTD validation tool to use? Do you have it or know where to get it. Finally, have you started the process for signing up for the ESG. As I mentioned earlier, some of the steps in this process can take some time while waiting for responses from the FDA.
- Next, you’ll want to make sure you understand these new requirements along with these new concepts and terminology. For example, if your documents are primarily in paper, how will you make them electronic and compliant with requirements? You should make sure you understand which sections – or modules – of the eCTD are applicable to your time of DMF. Type II and Type III DMFs will typically use different sections of the eCTD, for example. And I can’t say this enough: get yourself set up for the gateway. Give yourself time to do things like get your digital certificate, sign up for your test account and understand how to interpret the possible responses you can get back from the gateway after sending a submission.
- Now here at step 3, the assumption is that you have by this point selected an eCTD solution. Why? Because one of the very first things you’ll need to do is submit what is called a sample ESG submission. In order for you to actually send real submissions through the gateway, the FDA requires you to submit a sample ESG submission through your Test account – this is the first ESG account you’ll get. The goal of this sample ESG submission is to assure the FDA that your actual submissions will comply with the technical requirements and expectations they have. Until you have a successful sample ESG submission, the FDA will not promote your test account to a production account.
- Now you’re ready! You’re ready to actually create your DMF submission in eCTD format. Key checklist items here include organizing your documents, constructing your submission and creating a test submission output that you can run through the agency’s validator. And once you’ve passed those validator tests, you’re ready to produce your final submission and send it through the gateway. Again, knowing the types and the meaning of gateway responses will be important in case you may need to re-submit for some reason.
- Finally, you’re ready for managing the lifecycle. By this I mean handling your subsequent submissions after that first time. It will be important to know things like the schedule for your annual reports, what kinds of amendments are coming and how to organize those documents, handling any health authority correspondence, and of course, submitting your LOAs when and as needed.
- So, having reviewed this substantial checklist, how can Cunesoft help you? Well, we think we can help you in several ways: by ensuring and guaranteeing eCTD compliance with cune-eCTD, offering you our expertise and real-life experience in producing eCTD submissions ourselves, enabling you to control your submission documents with our integrated cune-RDMS module, and finally providing you with smart, responsive support from around the world. By combining our products, people and process, Cunesoft is uniquely positioned to provide you with the best possible roadmap for your DMF journey. We hope you will allow us to help you!
- And before we wrap up with a Q&A session, I did want to share with you a few useful links. The first is for the Validator tool used by the FDA – you can download it for free and use it just like the FDA does. We’ve also included a link to the ESG page that gives you lots of information about how to get yourselves set up for the gateway, and finally, a link to an FDA presentation from last year about the move to eCTD for DMF submissions.
- And before we wrap up with a Q&A session, I did want to share with you a few useful links. The first is for the Validator tool used by the FDA – you can download it for free and use it just like the FDA does. We’ve also included a link to the ESG page that gives you lots of information about how to get yourselves set up for the gateway, and finally, a link to an FDA presentation from last year about the move to eCTD for DMF submissions.
- And before we wrap up with a Q&A session, I did want to share with you a few useful links. The first is for the Validator tool used by the FDA – you can download it for free and use it just like the FDA does. We’ve also included a link to the ESG page that gives you lots of information about how to get yourselves set up for the gateway, and finally, a link to an FDA presentation from last year about the move to eCTD for DMF submissions.
- And before we wrap up with a Q&A session, I did want to share with you a few useful links. The first is for the Validator tool used by the FDA – you can download it for free and use it just like the FDA does. We’ve also included a link to the ESG page that gives you lots of information about how to get yourselves set up for the gateway, and finally, a link to an FDA presentation from last year about the move to eCTD for DMF submissions.
- And before we wrap up with a Q&A session, I did want to share with you a few useful links. The first is for the Validator tool used by the FDA – you can download it for free and use it just like the FDA does. We’ve also included a link to the ESG page that gives you lots of information about how to get yourselves set up for the gateway, and finally, a link to an FDA presentation from last year about the move to eCTD for DMF submissions.
- And before we wrap up with a Q&A session, I did want to share with you a few useful links. The first is for the Validator tool used by the FDA – you can download it for free and use it just like the FDA does. We’ve also included a link to the ESG page that gives you lots of information about how to get yourselves set up for the gateway, and finally, a link to an FDA presentation from last year about the move to eCTD for DMF submissions.
- And before we wrap up with a Q&A session, I did want to share with you a few useful links. The first is for the Validator tool used by the FDA – you can download it for free and use it just like the FDA does. We’ve also included a link to the ESG page that gives you lots of information about how to get yourselves set up for the gateway, and finally, a link to an FDA presentation from last year about the move to eCTD for DMF submissions.
- Thank you Daniel. I certainly think that this should give our guests a much better idea about how cune-eCTD can and will make the transition to eCTD much easier when it comes to DMF submissions. Now we have another quick poll that we’d like to share with you. You’ll see the poll question on your screen and you can simply click on your response. Basically, we would like to know about your biggest concerns regarding the move to eCTD. You can check all that apply for: Transitioning from my current documents to eCTD documents Knowing where to my documents in an eCTD Planning and managing my eCTD submission activities Using the FDA Electronic Submission Gateway (ESG) Validating my submission before sending it to the FDA AFTER POLL: I want to thank all of you for sharing your opinion here today. I certainly hope that we meet your expectations and should you have any questions, please remember that we will have a q&a session at the end of the webinar today.,
- So now we’ll do some Q&A