Category: EMA

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, 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 …

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 …