Like what you read? Get new posts delivered straight to your inbox!
Contact Us | Follow Us
Experience. Integrity. IMPACT.
What We Do

What I Learned at the 2017 DIA RSIDM Conference

March 23, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

I was fortunate enough to attend the 2017 DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum again this year. As usual for this conference, I learned a lot and got a lot out of it.

The big news this year was…the lack of big news. Let me explain.

In 2015 the FDA announced the eCTD mandate, and in 2016 FDA announced the new Module 1 specification and important updates to the Electronic Submissions Gateway (ESG). This year there weren’t any big announcements from FDA. Instead there were some incremental changes, mostly around the ESG (some of those upgrades announced in 2016 went live for testing on the first day of the conference) and study data standards (hmmm, I feel another blog post coming on).

Fortunately the sparse news from FDA was made up for by some really interesting presentations. I’ve summarized some of them below and added my opinions. Here we go!

EDMS in the 21st Century: Better, Broader, More Flexible

(Presented by Rick London of GlobalSubmit, Patricia Santos-Serrao of Mastercontrol, and Dimitri Stamatiadis of MAIA Consulting)

Electronic Document Management Systems (EDMS) have been around for a long time—my first entry into pharma was training a company on the Documentum EDMS in the late 90s—so they’re pretty mature now. But the advent of mobile technology and growth of small pharma has forced the industry to adapt themselves to a different user community. In addition, the increasing popularity of the electronic Trial Master File (eTMF), especially (again) for small pharma, has forced vendors to adapt to a user base they didn’t pay much attention to until recently.

All of this means that the current generation of EDMS tools is very different from the “old school” EDMS. Today’s EDMS should allow users to review and approve documents from any device, not just sitting at a laptop, and should accommodate different data structures than just the typical 5-module eCTD format many of us have become accustomed to.

What does this mean to you? If you’re in the market for an EDMS you’re in luck. A bunch of people from pharma and the EDMS vendor pool got together and created a set of simple, common requirements that cover 90% of the needs of any small company based on agreed standards and reference models (like the eTMF model).

These requirements are called “Pocket EDMS” and they’re available at That site also has a list of vendors and products that meet the requirements; essentially this is a shopper’s guide to picking an EDMS that meets your needs.

Following the Sun: Regulatory Ops in Global Organizations

(Presented by Christian Buckley of Astellas, Jennifer Costello of Teva Pharmaceuticals, Mary Potok of MMS Holdings, and Timm Pauli of PharmaLex GmbH)

Because of my own personal background—I worked for a large pharma company until they started offshoring my skills—I was interested to attend this one and hear about the latest trends and challenges of the offshoring movement.

Ms. Costello and Ms. Potok had very different experiences from mine. In both cases their organizations used offshoring to supplement, not replace, the US/UK workers already doing the jobs. Both gave practical tips on how to accomplish this and some of the challenges in getting it right (cultural and communication differences; fears of job loss; effective ways to hand off documents, etc.). The end result for them was a publishing team which literally follows the sun—their teams hand documents off to each other as each group goes offline for the evening.

Used with permission from Timm Pauli.

Mr. Pauli’s presentation was less about follow-the-sun practices and more about improving overall regulatory operations and changing the culture. He talked quite a bit about changing the “superhero” culture of Regulatory Operations, where RegOps does whatever it takes to bail out a submission (see the slide at the right).

I’ll admit that in the past I’ve been totally guilty of this approach. Fortunately at IMPACT we have a team that works really well together to share workload and we work with our sponsors to help them work smarter, not harder. If you see your RegOps group having to constantly be superheroes in order to meet timelines, I’d suggest looking at how your company works and see if you can improve your culture or your processes. IMPACT can help you develop ways to ensure you receive submission-ready documents up front so you’re not fixing things on the back end and at the last minute.

IND eCTDs: Transition from FDA Appreciating to Requiring eCTD INDs

(Presented by Daniel Offringa of Pharmaceutical eConsulting, Daniel Orfe of Regulatory eSubmissions, Emily Hall of ACADIA Pharmaceuticals, and Gina Ross of Cardinal Health)

This session was meant to give people pointers on when and how to switch from paper INDs to electronic. Much of the information in this one aligned closely with my Electronic Publishing series (hearing people agree with me felt like validation!), though there were a few points I haven’t covered in other blogs (which of course means…ideas for future topics!).

The big conclusion was don’t put it off any longer and I totally agree. Moving to eCTD doesn’t have to be painful; there are lots of resources available to help the transition. Here at IMPACT we’ve helped several companies make the switch and Kathy has written a blog post about some things to consider when making the change. If you have questions or think it’s time to switch (it is!) please don’t hesitate to contact us.

The Future of Electronic Submissions

(Presented by Jared Lantzy of Lorenz Life Sciences Group, Robert Connelly of GlobalSubmit, and Hans van Bruggen of eCTDconsultancy B.V.)

They could have called this presentation “eCTD v4” because that’s what everyone was there to see and hear.

This was, by far, the best presentation I attended and in fact it was so popular the room was full and there were dozens of people in the hall. Jared gave a similar presentation last year with Mark Gray of FDA as the panel chair (read our recap of that presentation) but there’s so much interest and concern around v4 of eCTD that they could do this weekly and people would probably attend (Mr. Gray actually attended this session and even though he said he didn’t want to get involved in the discussion he eventually started answering questions from the audience).

The most important thing to know is that eCTD v4 won’t happen for at least 3 years and even then it will undoubtedly be optional for a few years. As Mark Gray said last year, the new Module 1 spec will be optional for at least 2 to 3 years and that’s a relatively minor change compared to eCTD v4.

Rob’s presentation was first. He talked about the big picture of eCTD v4—what it is, how it works, and what it means for all of us. He repeated some of what Jared had said last year, but there was also some new information:

  • Nearly all your software will have to be updated (and maybe replaced?)

It’s more than just your publishing tool. Because of the reusability of documents within v4, your current DMS and Regulatory Information Management (RIM) tool (not to mention your viewer) won’t be compatible with eCTD v4.

  • Two-way communication with the agencies

If you read my blog post from last year’s RSIDM conference you know that I’ve wondered about this one for years. Rob and Jared finally had some more information on how this will work. For example, as a CRO would we be expected to daily check the gateway for FDA communication to our sponsors? No, that’s now how it’ll work: it will only be used for certain types of communication—things like approvals and other major transactions.

  • STFs will go away

Study Tagging Files often confuse new publishers and currently only the US agencies use them, so this probably shouldn’t be surprising. For those of you that are new to eCTD submissions, study tagging files are basically an electronic table of contents for study reports in Modules 4 and 5. They’ll be replaced with the additional metadata available in eCTD v4 around keywords and ContextOfUse. Speaking of ContextOfUse…

  • ContextOfUse explained further

ContextOfUse is a totally new concept in eCTD v4. The idea behind it is that one document might be used in multiple submissions and even applications, but in one submission it might have a very different meaning and purpose than others. Honestly I’ve had a hard time thinking of a practical example but I think I came up with one. Let’s say you submit a Phase 2 asthma study to your asthma NDA. Now you’re submitting a COPD NDA for the same drug. Because the CSR was for asthma it’s a different indication, and thus the ContextOfUse would be different.

Jared Lantzy spoke next. He and the team at Lorenz have been field-testing eCTD v4 using the ICH and Draft EU Regional Implementation Guides as guidance for how things will work. They partnered with a regulatory agency to have them review the submissions (by the way, it seems that in eCTD v4 submissions will now be called “messages”) and give feedback. He had a lot on information for us but here I’ll focus on what it means for publishers:

  • It’s not that different from building an eCTD 3 submission

As with v3, the process is still basically the same—assign documents to headings, add metadata, and link.

  • However the metadata, and what it’s called, has changed

As you’ve seen from my ContextOfUse explanation, there’s a bunch of new vocabulary associated with v4. In addition there will be new metadata required, though I’m not sure at this point what it will be.

  • Because of the new reuse capabilities, EU regulatory affairs will be (even more) complicated

Jared said their testing showed EU submissions will be much more complex. Why? Well, a big change with v4 is the ability to reuse a document across multiple submissions simply by referring to its unique identifier (called the “UUID”). With the nature of EU applications (National procedures, Mutual recognition procedures, etc.) conceivably you could just submit to one national agency and then submit to others by simply “pointing” at those other documents BUT only if the documents have been accepted by the first agency. This leads us to the next point…

  • More reuse issues

With this ability to reuse documents, publishing tools (especially RIM tools, but also DMS) and sponsors will have to track where a document has been accepted before attempting to reuse them. For big pharma especially, where companies often have detailed global plans to approve products in short periods of time this would seem particularly challenging.

Regarding all these reuse concerns; I expect that these will hit the big pharma companies for a long time before they trickle down to the smaller companies and startups. With that being said, these potential issues will still be a headache for the tool vendors because they have to build in these capabilities regardless of whether their clients intend to use them in the short term.

The final speaker was Hans van Bruggen. As usual he had some really great ideas and presented them well. He talked about better ways to leverage the metadata inherent in eCTD, especially in Module 3, to make it easier to manage large submissions (for example, incorporating dosage form and strength in leaf titles). I was happy to realize we already make use of many of these ideas here at IMPACT when naming our documents. Again, it’s great to get validation that we’re doing things “the right way.”

Usually the last session of the conference is really useful as a panel of FDA experts answer questions submitted by attendees during the conference. This year there weren’t as many questions submitted (I usually give 2 or 3; I didn’t have any this time) and in my opinion the questions asked were very detailed and unique to the situation of the person asking. As a result I really don’t have any big ones to share this time around.

Category: Regulatory Operations
Keywords: RSIDM, DIA, Electronic Document Management Systems, EDMS, eCTD v4, electronic publishing, electronic submissions

Other Posts You Might Like: