For medical device companies, accurate and consistent data is critical for regulatory compliance and patient safety. Master Data Management (MDM) is an essential process that
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and
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
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
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
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
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.
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
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
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
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
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
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
“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.”
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
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
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,
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
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
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