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 …

eCTD, EMA, Health Canada, Regulatory Update

Regulatory Updates: European Electronic Application Form and Health Canada eCTD Mandate

Joel Finkle, Director Regulatory Innovation and Donald Palmer, Director Product Strategy A couple of announcements have been received from regulatory agencies impacting product application processes. European Electronic Application Form (eAF) First, EMA has updated the electronic Application Form (EAF). This is the interactive PDF form from which EMA extracts an XML representation of what your …

EMA, IDMP, SPOR, XEVMPD

Would you support IDMP that isn’t IDMP?

Joel Finkle, Director Regulatory Innovation & IDMP Strategy For the last few months – both at the January and March EU IDMP/SPOR Task Force Meetings, there has been debate about how to send IDMP data to agencies in Europe. Although the ISO standard specifies the HL7 SPL format, the initial iteration of EMA’s implementation is …

eCTD, eCTD 4, FDA

eCTD 4 — A Love/Hate Relationship

Joel Finkle, Director Regulatory Innovation & IDMP Strategy, ACUTA Don’t get me wrong: I definitely love eCTD 4 for all the things it’s been designed for. However, we’ve been working on it since 2005, and we’re still years away from its full implementation.  So, I thought I’d make a love and hate list to show …

ARCS, ARIM Publisher, eCTD, eCTD 4, FDA

eCTD – It’s not just a good idea, it’s the law

Joel Finkle, Director Regulatory Innovation & IDMP Strategy Note: This post appeared previously on LinkedIn.com Some of you have been following my writing for a few years; I’ve got a new home at Acuta. For others, this may be the first you’ve seen of my posts. I’ve been involved with electronic regulatory submissions since 1991 …