Tag: ARIM

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 …

ACUTA, Conferences

Join ACUTA at the 6th Annual Regulatory Operations and Submissions Conference

The 6th Annual Regulatory Operations and Submissions Conference takes place May 22-23 in Philadelphia at the Wyndham Historic District. Please join Don Palmer, Director of Product Strategy, and Joel Finkle, Director of Regulatory Innovation at their table, in between sessions on submission management, cloud systems and outsourcing, and technology challenges. We’d love to talk to …

ARIM Registrations, EMA, IDMP

IDMPrimer #1: The Four Quadrants of IDMP Data

Once upon a time, I’d written a number of lessons on IDMP – those are no longer easily available (hint: check out the Internet Archive, but come back here), and there have been changes, so let’s start from scratch. If you need a glossary of abbreviations below, please check out the April 25 blog post. …