Brexit, EMA

Brexit Update – Amsterdam Wins EMA Host City

As posted by the BBC, EMA has made their decisions on where to locate the European Medicines Agency (EMA) and European Banking Agency, because of the need to relocate once Britain leaves the European Union (aka Brexit). Amsterdam will be the new host city for the EMA, with permanent office space becoming available around August …

ARID

The Old Equations

Credit M. Kemal https://www.flickr.com/photos/23221002@N00/7204014842/in/photolist-bYAsCs-64RZB1-q34MyH-7QhvAS-5kBGaM-sbmQwc-8xhWdj-aQmwe2-aQmw2H-aQmw1g-7g4nCq-aQmwbp-xDxNy-aQmw4v-aQmwfn-aQmw6r-aQn6hX-FH3RYP-aQmwkn-5cXYr-4s8uCX-7eALhs-fHxKgh-6HsCtz-cMpT5h-dkAv3z-dS6ThJ-fHh26r-fHyEjj-5nJzqU-cMpT33-6DxhSz-61Pdc-ZtZM-8JXn7H-4ZUia7-sJC1j-fHgUZt-b7NQqR-5H5z6S-4GiCre-5cXYq-5Lu4yz-wgXj7z-Z1P7Jm-bnZtgV-j8EtXM-5RpyD-8TU8VK-4qqqdU

Especially because we now offer a Microsoft Word-based tool, ARID (ACUTA Regulatory Intelligent Documents) I thought it would be important to point out a recently discovered vulnerability in Microsoft Office.  The original Equation Editor — a 17-year-old component — has been shipped with all versions of Office since that point, and has been found to permit …

APT, ARCS, Software Release

I’m APT to be a little excited over version 4.0

The holidays came almost two months early for users of ACUTA PDF Tools (APT) as version 4 was released on October 31, 2017. With the new release, APT continues to evolve to work with new guidance, as well as features that improve publishing processes for Bio/Pharma companies using it to assemble their submission-ready documents. A key …

ACUTA, ARCS, ARIM, eCTD, FDA

Six Months until Mandatory eCTD for INDs, DMFs at FDA

Almost seven months ago, I posted my first ACUTA blog entry on the FDA requirement for eCTD for all marketing applications, a little under a month before the May 5, 2017 deadline. The sky didn’t fall, companies didn’t fold for being unable to comply… and ARCS (ACUTA Clinical & Regulatory Services) helped numerous companies achieve …

ACUTA, ARCS, ARIM, Australia, eCTD, NeES

E-Submissions Looking Up Down Under

Australia’s Therapeutic Goods Administration (TGA) released updated guidance for both eCTD (electronic Common Technical Document) and NeES (Non-eCTD Electronic Submissions). Version 3.1 of the Australian regional eCTD specifications, and version 2.0 of the NeES specifications will be accepted starting January 1, 2018, and will be mandatory July 1, 2018. Because the eCTD and NeES are …

Conferences, Uncategorized

DIA Canada October 16-18

Sorry for the short notice, but please come hear me present IDMP: International Data, Multiple Processes at the DIA Canada annual meeting in Ottowa October 16-18. I will be speaking in session 4C at 3:30PM on October 17, in the session Identification of Medicinal Products (IDMP)- Updates and Implementation Approaches, chaired by Maggie Graham of Health …

Brexit, EMA

Brexit Update: EMA Prefers Amsterdam

This is just a quick update on the status of the move of the EMA headquarters from London, due to the UK leaving the European Union, generally known as Brexit. The IDMP “SPOR” Master Data Management project at EMA is expected to be delayed due to the move, but IDMP is the only project known …

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 …