Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.
ACUTA, ARCS, ARIM, eCTD, EMA, FDA

Your Holiday Gift: eCTD for Everything

A month ago, we reminded you that electronic Common Technical Document (eCTD) will be the rule for all US drug submissions on May 5, 2018, adding Master File and Investigational New Drug applications to the already-required New Drug Applications. What I’d neglected to mention is that eCTD is also expanding in 2018 for European submissions. …

ARIM, ARIM Publisher, eCTD, eCTD 4, XML

eCTD 4: Unlocking Keywords, Part 2 (wonkish)

In the most recent post on eCTD 4 I explained the basics of how metadata that classifies documents in the electronic Common Technical Document (eCTD) is organized, and how ACUTA’s ARIM Publishing Module will need to evolve to support it. This post is going to get into the specifics of what must go on behind …

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 …