The EMA’s eCTD 4.0 pilot is entering its next stage, and Ennov is ready to support Marketing Authorization Holders (MAHs) who are participating. Following our
The Challenge Japan’s move to eCTD 4.0 has created more questions than answers for pharmaceutical companies. For one of the world’s premier pharmaceutical companies, the
1. Introduction: Why IDMP and xEVMPD Matter More Than Ever If you work in regulatory affairs or operations in life sciences, you’ve likely encountered the
Regulatory teams know the feeling: your documentation is complete, the submission plan is sent, and yet, you’re still waiting days for your submission to be
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that
Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41%
As Life Science professionals, we often find ourselves at the crossroads of scientific innovation, compliance, and strategic business initiatives. Yet, how often do we pause
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and
Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is
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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