Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
November 2, 2022
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this
September 5, 2022
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
August 29, 2022
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
August 22, 2022
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
August 19, 2022
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
February 23, 2022
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
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
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
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
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
January 19, 2021
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will
December 18, 2019
Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and
October 10, 2019
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