Category: EMA

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 …

Canada, eCTD, eCTD 4, EMA, FDA, Health Canada

eCTD 4: Everybody in the pool! But no running!

This year’s Regulatory Information, Submissions, and Document Management forum presented by the DIA took place February 4-7 in Bethesda Maryland. I saw a lot of old colleagues from my employers over the decades, now dispersed throughout the industry, and heard a lot about where Regulatory Information Management is heading. For me, the most fascinating part …

EMA, IDMP, SPOR

IDMP and SPOR: EMA Plans Published

One of the biggest concerns about implementation of IDMP in Europe has been that the plans were vague, and slipped frequently. European Medicines Agency (EMA) has just published a presentation with a detailed roadmap for the SPOR project and IDMP. The IRISS Forum also posted a summary of recent activity, but it’s limited to IRISS …

ARIM, EMA, IDMP

IDMPrimer: What we don’t know

IDMP Club

It seems the first rule of IDMP Club is the same as Fight Club: Don’t talk about IDMP Club (it’s probably the second rule too). I’m a member of some of the branches of IDMP Club, but not all. IRISS Forum probably has the most open exchange of information. I’d highly recommend joining if you …

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. …

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 …

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 …

Brexit, EMA

What does Brexit mean for Pharmaceutical Companies?

The whole world is holding its breath to see whether Britain’s withdrawal from the European Union, nicknamed “Brexit,” will have a “hard” landing – meaning a strict break with the European common market and open emigration – or a “soft” one, meaning that some parts of the treaty may be maintained. Theresa May, Prime Minister, …

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 …