ARIM, EMA, IDMP

And if IDMP never happens?

Well, for one, it will. European Parliament has legislated that it must.  But it could come in many different forms, perhaps with nothing more than the minimal data to determine a Medicinal Product ID that gets used on an Adverse Event Report. That means the following items are the barest minimum of data that must be …

ACUTA, ARIM, ARIM Publisher, eCTD, FDA, Uncategorized, Validator

FDA Validation Criteria to change July 27

On June 21, FDA announced changes to their eCTD validation criteria, to be implemented on July 27. The first is to remove a low-severity item, #5025, which would highlight the lack of PDF-fillable forms. The rest are a set of new validation rules, numbered 1-7, that were previously part of their Submission Acceptance criteria — …

ACUTA, ARID, EMA, FDA, Health Canada, Software Release

ACUTA Regulatory Intelligent Documents (ARID) v1.1 Released

I’m pleased to announce that ACUTA has released version 1.1 of the ACUTA Regulatory Intelligent Documents, or ARID for short. ARID is a set of over 325 shell documents (up nearly 50 from the previous version) and a carefully curated set of Word tools combined with the most-used features from the ribbon, on a single …

Conferences, IDMP

Speaker’s Corner June 2018

The big news right now is that at the last minute, Joel Finkle has been asked to speak as a substitute at the Q1 7th Annual Regulatory Operations and Submission Publishing Strategies Conference in Boston, June 14 and 15. I will be presenting an overview of IDMP, the EU approaches to implementing it, and how …

APT, Software Release

ACUTA PDF Tools (APT) version 4.1 released

ACUTA PDF Tools has been updated to version 4.1. It has been enhanced to include the following key features (as well as a few others). TOC Generator Wizard – this is a new tool, that can create TOC pages from the bookmarks (or manual entries) of an existing PDF file PageStamp Wizard – this is a …

ACUTA, ARIM, Conferences, eCTD

ACUTA RIM Shots May 18, 2018

Every once in a while there will be only short subjects to report on Regulatory Information Management-related topics, so welcome to the first ACUTA RIM Shots, where we’ll report on quick news items. ACUTA to Present at Pharmaceutical Regulatory Affairs June 8 Joel Finkle, Director of Regulatory Innovation and IDMP Strategy, will have two presentations …

ACUTA, ARIM, Australia, eCTD, Validator

ACUTA Validator now listed by the Australian agency

In November of 2017, we reported the details of Australia’s updated guidance for version 3.1 of their regional eCTD specifications. ARIM Suite Version 3.2, which was released shortly after that, provided full support for publishing and validating Australian submissions. While ACUTA Validator has been capable of accurately validating submissions to Australia’s Therapeutic Goods Administration (TGA) …

ACUTA, Conferences, IDMP

Join ACUTA at the eRegulatory Summit in Lisbon, April 24-26

ACUTA is proud to be presenting and exhibiting at Informa’s eRegulatory Summit conference at the SANA Hotel, Lisbon on April 24-26, 2018. Joel Finkle, ACUTA’s Director of Regulatory Innovation and IDMP Strategy will be speaking on the 26th, at 16:20, presenting “The RIM around IDMP – How to fill it up” with examples of data …

ACUTA, ARCS, ARIM, eCTD, EMA, FDA

eCTD – What are you waiting for?

I’ve now been with ACUTA for a full year – this blog started about two weeks after I joined the company. From that first post, we’ve been reminding you that the electronic Common Technical Document (eCTD) – the way of packaging up everything from the thousands of documents to get a drug approved, or just …

ACUTA, ARCS, ARIM, ARIM Publisher, FDA, Software Release, Validator

Getting your STF in order

In 2003, ICH introduced the Study Tagging File (STF) in the electronic Common Technical Document (eCTD) format for electronic submissions to facilitate a way to associate all the documents and data files for a study. Initially the specification included two possible approaches for versioning the study’s items: Cumulative: A complete cumulative STF would be provided …