The global clinical research landscape is undergoing a transformative shift with the adoption of ICH E6(R3)—the much-anticipated revision of the International Council for Harmonization’s (ICH)
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
Clinical trial technology is supposed to streamline operations, not slow them down. But too often, the stack becomes the source of delay. This checklist outlines
Picture this: Your Quality team discovers a manufacturing deviation requiring immediate global notifications. But instead of a streamlined response, disconnected systems force manual work: exporting
Life sciences organizations face mounting pressure to accelerate regulatory processes while maintaining rigorous quality standards. Whether ensuring compliance, expanding globally, or managing complex product portfolios,
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
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s
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 December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on
In today’s digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while
In today’s digitized world, data is often termed as the “new oil.” The Life Sciences industry, rich in complex processes and critical operations, generates vast
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
In the evolving landscape of the Life Sciences industry, growth and diversification are constants. From expanding into new markets, and developing innovative products, to integrating
In an era marked by rapid technological advancements and increasingly interconnected business ecosystems, the call for seamless integration in Quality Management Systems (QMS) has become
The cosmetics industry is constantly changing, making safety data management a unique challenge. To adhere to global regulations, cosmetic companies need a versatile Cosmetovigilance (CV) system that
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety.
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs
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
The life sciences industry is rapidly evolving, and emerging pharmaceutical companies are at the forefront of this disruption. Companies leverage streamlined operations, nimble teams, and
The Life Sciences industry is undergoing a period of rapid transformation. As we progress through 2023, several critical trends have emerged, each presenting unique opportunities
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
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner’s latest Market Guide
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
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
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of
As clinical trial complexity increases, life sciences companies must have a technology strategy that supports research, development, and commercial business units. A recent Gartner report,
The pharmaceutical industry plays a critical role in ensuring the health and well-being of people all over the world. With this important responsibility, it is
Healthcare and Life Science CIOs are facing mounting pressures to manage costs, optimize resources, and deliver value in an environment characterized by competing priorities and
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision.
The life sciences industry is at the brink of a digital transformation, with economic pressures and disruptive technology and innovation challenging traditional business models. A
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
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
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand
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.
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
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
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
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
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
“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
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
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
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate,
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to
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,
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume
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
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
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
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical
[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with
With the release of the new Eudravigilance system on 22nd November 2017, the European Medicines Agency (EMA) have introduced greater access to adverse event data
[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to
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