Tag: ARIM

ACUTA, ARIM, ARIM Publisher, eCTD, EMA, FDA

Lots of Regulatory Activity Going On

Welcome to another episode of Fun With RIM (kidding, this is the first one). Today’s topic: Just what is a Regulatory Activity? You’ll say to yourself, “I’m in Regulatory, and I do things, so those must be Regulatory Activities.” Not counting that 15 minutes to two hours that half the workforce spends every day on …

ACUTA, ARIM, Software Release

ACUTA Ships ARIM 3.1, ARIM 2.3.3 and Validator

As you can see in the photo above, we have been putting tremendous effort toward shipment of the latest releases of the ARIM (ACUTA Regulatory Information Management) system. Shy Kumar, Founder and CEO of ACUTA, said this of the new releases: The ACUTA team continues to innovate with a focus on bringing new capabilities and …

ACUTA, APT, ARIM Publisher, eCTD

PDF Links Feel So Broke Up, I Want to Go Home

PDF in Electronic Submissions Before there was eCTD (the electronic Common Technical Document), there were submissions using just PDF – the Portable Document Format created by Adobe (and before PDF, there were submissions using interactive PostScript, TIFF images, DAMOS, etc., but that’s a scary story for another time, perhaps around a campfire) The PDF file …

ARIM Registrations, EMA, IDMP, XEVMPD

XEVMPD: Unpacking its impact on IDMP

Note: This article is not a commitment to features or capabilities of ACUTA products or services. When ACUTA added the Registration module to to ARIM version 3.0 in 2017, our expectation was that IDMP (Identification of Medicinal Products, the ISO standards being implemented first in Europe) was imminent. Because of that, we expected it would …

ARIM Registrations, EMA, IDMP, SPOR

IDMPrimer #3: Building Blocks

So far in the first two primer posts I’ve described some over-arching concepts about the data that goes into IDMP, how it’s used, and where it comes from. Let’s start piecing things together and understand what an IDMP message would look like. I promise not to use XML for now – the HL7 Structured Product Language …

ARIM Publisher, eCTD, EMA, Regulatory Update

Regulatory Update: EMA eCTD Specifications 3.0.2 – Best Practices Limitation Corrected (even better practices!)

On April 6, 2017, EMA issued a new version of the eCTD specifications, version 3.0.2, 11 months after version 3.0.1. If you look at the EMA Website’s EU Module 1 page, it appears that nothing has happened: The same EU Regional DTD (the structure of the eCTD), and the same Implementation Guide are listed as …

ACUTA, Conferences

Join ACUTA at the 6th Annual Regulatory Operations and Submissions Conference

The 6th Annual Regulatory Operations and Submissions Conference takes place May 22-23 in Philadelphia at the Wyndham Historic District. Please join Don Palmer, Director of Product Strategy, and Joel Finkle, Director of Regulatory Innovation at their table, in between sessions on submission management, cloud systems and outsourcing, and technology challenges. We’d love to talk to …

ARIM Registrations, EMA, IDMP

IDMPrimer #1: The Four Quadrants of IDMP Data

Once upon a time, I’d written a number of lessons on IDMP – those are no longer easily available (hint: check out the Internet Archive, but come back here), and there have been changes, so let’s start from scratch. If you need a glossary of abbreviations below, please check out the April 25 blog post. …