Tag: EMA

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 …

ARIM Publisher, eCTD, EMA, Regulatory Update

Regulatory Update: EMA eCTD Specifications 3.0.2 – Best Practices Limitation Corrected (even better practices!)

On April 6, 2017, EMA issued a new version of the eCTD specifications, version 3.0.2, 11 months after version 3.0.1. If you look at the EMA Website’s EU Module 1 page, it appears that nothing has happened: The same EU Regional DTD (the structure of the eCTD), and the same Implementation Guide are listed as …

eCTD, eCTD 4, EMA

eCTD 4 in Europe: Multiple Countries, Multiple Processes

For the first time in two years, EMA (there are enough acronyms here that it got distracting defining them all – see the table at the bottom) has updated their Implementation Guide for eCTD version 4, which is based on the HL7 RPS standard, and has been advanced through ICH Step 4, meaning that it’s OK …

EMA, IDMP, SPOR

IDMPrimer #2: EMA’s Operating Model

Last time, the subject was the overall data in IDMP (The ISO standard for Identification of Medicinal Products), and how it grouped into regulatory vs non-regulatory, and the description of the product itself versus what it’s authorized for. This lesson is about how all that data is going to be used, and how that influences …