Month: May 2017

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 …

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. …

ACUTA

New ACUTA Headquarters Signals Expanded Services

ACUTA Headquarters

Effective May 1, ACUTA has a new home in Marlborough, Massachusetts.  According to Shylendra Kumar, Founder and CEO, I am very proud and pleased to see the exponential growth of ACUTA over last 3 years! ACUTA is doubling in size consistently every year since last 3 years and we are moving to a new and …