APT, ARCS, ARID, ARIM, Conferences

Speaker’s Corner, 4Q 2018

Joel Finkle will be speaking at the Drug Information Association (DIA) eDM 2018 – Clinical and Regulatory Operational Excellence Forum in Barcelona Spain, November 29-30, 2018. He will be speaking on the intersection of Component-Based Authoring (CBA) and Regulatory Information Management (RIM), in a presentation titled, “All the Way Around the RIM: From Registration Data …

ARIM, Software Release, Uncategorized

ARIM 3.3 Hotfix 1 Released

ACUTA (an IQVIA company) is pleased to announce the release of ARIM version 3.3 Hot Fix 1. This release includes a number of customer-requested updates and fixes. The key improvements are to our support for Veeva Vault repositories The use of Okta authentication has been made a System Setting, permitting it to be set up …

ARCS, ARIM, Canada, Health Canada, Medical Devices

Health Canada Updates Medical Device Submission Format

Canada XML

On August 21, Health Canada announced that they would be adopting the IMDRF “ToC” format for medical device market authorisation requests. As of April 1, 2019, Premarket Applications for Class III and IV devices (which aren’t the same classification as FDA’s Center for Devices and Radiological Health) will need to be in this format, and …

Brexit, Regulatory Update

ACUTA RIM Shots – August 16 Special Brexit Edition

Lots of Brexit-oriented news in recent days that affects the biotech industry. UK/EMA Separation Implementation Period First of all, in March, the EU and UK agreed to an ‘implementation period’ for medicines to give a little more time for the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to  …

Brexit, EMA

Can the UK stay in the EMA post-Brexit?

On July 17, 2018, the UK Parliament voted to remain in the European Medicines Agency (EMA) after Britain withdraws from the European Union (“Brexit”). This is not a done deal: the vote only means that the UK government must negotiate to continue to participate in the EMA. This will probably involve negotiating an appropriate payment …

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 …