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Author Archives: BJ Witkin

Publishing an eCTD Clinical Study Report: ICH E3

August 15, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

Because IMPACT writes and publishes so many CSRs, we get a lot of sponsors asking us questions about how CSRs should be published. This tells me that there’s a lot of confusion about CSR requirements and, in my opinion, some of that confusion stems from ICH E3. I thought I would use Ilana Dew’s recent blog post about ICH E3 as a jumping-off point from which to talk about what that document means to us as publishers.

In her post, Ilana discussed the medical writer’s perspective on transparency and flexibility in E3. I’m really glad she brought up flexibility because as a publisher advising sponsors about CSR publishing, the first thing I tell them is that ICH E3 is a guideline, not a guidance.

In fact, in 2012 the ICH E3 working group even released a Q&A document to state this very clearly because sponsors were asking about it. Thus, we do our best to comply with the spirit of E3 while also meeting the needs of electronic submissions.

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Dispelling Misconceptions: Converting from Paper to eCTD Submissions

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

Over the years I’ve heard a whole bunch of misconceptions and misunderstandings about making the change from paper submissions to eCTD. Since the deadline to convert NDAs, ANDAs, and BLAs has recently passed (May 5th, 2017) and the deadline for INDs and DMFs is now a little less than a year away (May 5th, 2018) I thought I’d address some of them.

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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.

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Submitting Drug Master File Submissions to Health Canada – Lessons Learned

November 7, 2016 | BJ. Witkin, Senior Manager | Regulatory Operations

Health Canada has recently announced two major initiatives which greatly affect regulatory submissions in general and Master Files (commonly called Drug Master Files) specifically.

First, Health Canada will now require that all electronic submissions (under 10 GB in size, which is most of them) be sent via their Common Electronic Submissions Gateway (CESG) effective January 1st of 2017. Note that this is 4 months ahead of the FDA’s mandate of May 5th, 2017 (see our previous post for details).

Second, Health Canada has released draft guidance on Master Files with very detailed changes to how they are laid out and submitted. It is very different from FDA Drug Master Files; one example is the Applicant’s Part/Restricted Part (as described below). If you haven’t read the guidance and are considering submitting to Health Canada, I urge you to read it.

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DIA RSIDM Recap: FDA’s Top 10 eCTD Validation Errors and Top 5 Reasons for Rejected Submissions

April 14, 2016 | B J. Witkin, Senior Manager | Regulatory Operations

Jonathan Resnick from FDA’s Electronic Submission Support Team spoke at the recent DIA RSIDM conference and told us the top 10 validation errors the FDA is seeing in electronic submissions. He also presented a table of the top 12 reasons for rejection. I thought I’d share these with you and discuss some of them.

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