Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
January 14, 2022
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Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
December 13, 2021
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
December 2, 2021
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
November 22, 2021
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated
October 14, 2021
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
May 6, 2021
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
April 22, 2021
Four Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management (RIM) system, they might say to provide replacement for spreadsheets, consolidate
April 2, 2021
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
March 24, 2021
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
February 2, 2021
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