As you may already know, under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Are you prepared?
Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. Your application must be technically sound and structured correctly. Most importantly, it has to be ready for review by the agency upon submission.
GlobalSubmit Inc., a leading developer of eCTD review and validation software for FDA use, wants you to be prepared for the trials and tribulations that occur while creating NDAs, INDs and related amendments.
That’s why GlobalSubmit is offering a free educational webinar Intro to eCTD on Wednesday, February 29th at 12:00pm EST.
During this discussion, we will provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. By the end of this session, you should feel better prepared to make the switch from paper to eCTD.
Top 3 Learning Objectives:
1. Understand eCTD terminology and rules
2. Realize the challenges of eCTD and solutions to address those challenges
3. Learn how to assemble a basic eCTD application
For more information and to register: GlobalSubmit Events
Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA. He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that.
So, last time, I told you about assembling a team of believers. Those believers are the “customers” you serve on both sides of the fence in regulatory operations. Not only are you getting documents from all the different members of the extended filing team (Regulatory, CMC, Pre-Clinical, etc.), but you’re then serving a different master in your health authority. If you need to review, please read the previous post.
This time, I want to focus on getting the most out of the tools and process which drives your efficiency. Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.
You could certainly PDF all your documents one at a time from MS Word and then code the XML in notepad. But, using the PDFMaker plug-in for word will automatically link your TOCs and cross-references for you and any of the software packages out there made for eCTD will do all of your XML for you. Tools that help you do that work have many different price points, enterprise license options, hosted solutions, etc. Just Google “eCTD software solutions” and you’ll see what I mean.
The point is, you do not need a million dollar, validated system to build your eCTD’s. But, eCTD lifecycle is a serious commitment, so you have to be prepared to have an ongoing relationship with those tools. The maintenance submissions far outnumber the original filing, so getting to know and trust the software companies that make those tools will be crucial to your success. There are point solutions, desktop solutions, web-based systems, hosted systems – the choices are many and varied.
Certainly, outsourcing is trending these days. There are some extremely capable partners with extensive eCTD experience out there. Do your homework, ask colleagues at industry meetings, go to message boards online. No software is perfect, and no vendors are perfect…but, some are better than others. This is a long term relationship you’re entering into, so do not take it lightly.
Be sure that the tools you select maximize your talent pool at your disposal. There are very few MS Word experts out there – so if you have one, maximize that potential and give the authors a break. Medical Writers in Pharma and Biotech do not need to be MS Word experts, but many operations groups do try to force them to be just that. They should be experts on science and data. Keep that in mind as you start to pull your submissions together.
In summary, much like building the best team, choosing the right tools that fit your needs is a very strategic and important decision. Look at all your options and choose wisely. Consider budget, long-term implications, and what makes the most sense for your situation before jumping into anything this big and in order to maximize the efficiency of electronic submissions.
Did that title catch you? Did you think I was going to reveal the secrets of pulling together millions of pages of data, reports, and information into a cohesive, user-friendly, searchable, and (one could argue) beautiful unit commonly called the eCTD? Well, sorry. There is no way to do it easily. In the upcoming several part series, I hope to take you through some of the things that I think will lead to a better experience navigating the unbelievable complexity that surrounds regulatory submissions. There’s a lot of science in there – good thing the publishers don’t have to actually read it.
Hopefully some of these tips and comments will help you not only make your submissions better, but also give you some idea of how to explain your job at parties.
First order of business, make sure that the extended team (by this, I mean everyone – the Regulatory liaison, the CMC rep, the pre-clinical teams, the regulatory writers, the senior leaders that chose the submission date randomly 2-3 years ago) understands that you will be the last one to touch their stuff and without you, the submission does not go to the agency. Also, make sure they understand that rushing it out the door may lead to it not getting filed at all. Do not be afraid to stand your ground, but choose your battles wisely. You may only get away with one threat per filing – so make sure it’s real. You are the gatekeeper. With great power comes great responsibility.
For example, cast your mind to the mid-1990’s when companies were still submitting paper in quintuplicate with different colored binders and hand-stamping page numbers. One company, in a rush to get a CD-Rom full of datasets out to meet a deadline on a submission, sent instead a CD-Rom of classical music to the agency instead of data. Needless to say, the agency, while they may have enjoyed the relaxing symphony selections, was unable to review the data. I digress…
Second order of business (and probably the most important), surround yourself with people who know what they’re doing, know the software tools at an expert level, and are extremely lazy. Yes, I said lazy. Do you know why? Efficiency born out of laziness is one of the most powerful drivers of innovation and automation. Why would I want to draw thousands of links in a Clinical Study Report by hand if I could write a linking script with an Acrobat plug-in that will do ninety percent of the linking in the background for me while I finish up the formatting on other documents? Or better yet, allow the linking script to run overnight so I can go home and be with my family instead of burning the midnight oil. The bottom line – whenever possible, work smart not hard (maybe lazy was too strong).
There’s a saying in carpentry – measure twice, cut once. The same applies to regulatory submissions. QC and make sure everything works before you send it out. Spend the time and care to be sure that what you’ve spent so much time preparing is right. Believe me, the one link you forgot to check is the only one the document control room will click on before they accept your submission.
More to come in part two…
This entry was written by Kathie Clark, former Director of Professional Services at GlobalSubmit and edited by Jen Watto, Marketing at GlobalSubmit.
The role of eCTD-ready source documents and their impact on submission timelines and publishing efficiency is a topic that has been debated for many years. There a lot of naysayers claiming that it’s not possible to compel scientists to produce submission ready documents, CROs cannot be made to comply with requirements, etc. Although there are different definitions of submission-ready, most people would agree that to be considered submission-ready, a document must be structured according to ICH/regional granularity rules, be bookmarked and internally hyperlinked, have a TOC if required, and have acceptable (preferably standard) headers, footers, and pagination. Others might go further to enforcing standard fonts, margins, etc.
I had begun to think that there was a light at the end of the tunnel when several recent DIA presentations reported that their rate of re-work due to receiving non-submission ready documents had decreased within the span of a year from a number in excess of 50% to less than 5% of submission documents. This was confirmed by the metrics cited during the presentations and panel discussions.
Interestingly, companies took several approaches to ensuring submission-ready documents:
Many sponsors report that source document QC is a tremendously time-consuming part of the submission process. GlobalSubmit 2010 has powerful features for accelerating the QC process, including:
We welcome any new ideas or feedback on how we can help you ensure submission-ready source documents.