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 from the European Union has…
One of the world's largest and most respected biopharma companies selected Ennov for its world-class Regulatory Information Management (RIM) system. This leader in animal health now has its entire product…
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 - all with limited resources…
A dynamic, all-in-one regulatory information management solution crafted for medical devices, pharmaceuticals, and combination products. The platform ensures continuous compliance, supports operational agility, and minimizes the risk of non-compliance across…
Ennov is proud to announce the successful integration of the Enterprise Technology division from Calyx into our organization. This strategic acquisition, completed on June 1, 2024, significantly enhances Ennov’s portfolio…
For small and mid-sized life sciences companies, maintaining quality standards amid constant industry evolution is an uphill battle. With limited resources and leaner teams, these businesses grapple with unique obstacles…
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 recent report, “Peer Lessons Learned…
Ennov is set to exhibit at the 2024 DIA Global Annual Meeting, taking place from June 16-20 in San Diego, CA. Be sure to visit us at booth #1427! The…
Medical device companies must navigate the complexities of new regulations like the EU's MDR/IVDR and the FDA's UDI requirements. These mandates demand a higher degree of traceability, transparency, and surveillance, underscoring the critical need…
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 Quality Management System Regulation (QMSR)…
Ennov is pleased to announce that we will be attending the 2024 CDISC + TMF Europe Interchange. The event is set to take place in Berlin from April 24-26, and…
Ennov is excited to announce our participation as a Bronze Sponsor in the upcoming Pronovea Pharma Summit 2024: Drug Safety and Risk Management. The summit is scheduled for April 24-25…
In this podcast, Ennov joins ION Pharma to discuss the complexities of modern quality management systems and how AI is becoming an indispensable ally in navigating the challenges of supply…
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 received to date can be…
Discover how Generative AI is revolutionizing drug development, healthcare, and regulatory compliance, shaping the future of the industry.
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 2022 and its 2023 amendment.…
A branch of computer science dedicated to creating systems capable of performing tasks that typically require human intelligence. These tasks include learning, decision-making, problem-solving, and pattern recognition.
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 Cosmetics Regulation 1223/2009 has brought…
In a pioneering collaboration, the leading entity in the luxury cosmetics industry, known for its commitment to innovation and quality since 1987, has partnered with Ennov to enhance consumer safety…
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 trust. Companies bear the critical…
In a landmark move for the life sciences industry, Ennov has acquired the 'Enterprise Technology' division from Calyx. This acquisition significantly expands Ennov's portfolio by integrating the advanced eClinical and…
In a move that signifies a major advancement in the life sciences industry, Ennov, a leader in regulated content management solutions, has acquired DocShifter, a top provider of document automation…
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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 the future of QMS, let's…
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
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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 and platforms for quality management,…
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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 regulatory landscapes mean that static…
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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 technical expertise levels. Amidst this…
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 complexity during innovation and expansion.…
Ennov is pleased to announce that we will be attending the 2024 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum as a Platinum Sponsor. This event will be held at the…
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 expanding markets. This balance…
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 regulations. Managing safety data sustainably,…
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 meeting global safety regulations. Scaling…
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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 amounts of data. But what's…
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
At Ennov, we believe in the power of collaboration to drive innovation. Our recent Medical Device Working Group session is a testament to this belief. This gathering of minds, featuring…
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 signifies not just adherence to…
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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 cutting-edge technologies, growth can take…
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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 not just a desire but…
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 evolves with the market. Choosing…
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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 landscape of QMS has…
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 cosmetics under the Federal Food,…
Join us on a journey to discover the key strategies for streamlining IDMP compliance without the burden of data re-entry.
Access this PV Safety Webinar on-demand to discover a comprehensive portfolio of PV Dashboards, and learn the methodology to design your own. Answering Key Questions What is my year-to-date picture?…
Webinaire La GED Ennov est désormais accessible en mode offline Le module déconnecté PC vous permet effectivement d’accéder à vos documents en cas d’indisponibilité du reseau: 15 minutes pour le…
Ennov is honored to announce that we are a Bronze sponsor of the 9th Annual European Drug Safety Pharma & Biotech Conference, a key event of the Pharmacovigilance World Tour.…
Tune in to gain insights from industry experts as they unpack the challenges and opportunities lying ahead for IDMP.
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 were discussed, what piqued my…
Ennov is pleased to announce a strategic partnership with ION Pharma. This alliance marks the beginning of a collaborative effort that merges over two decades of expertise in electronic Quality…
Ennov is thrilled to announce our attendance at the World Drug Safety Congress Americas 2023, taking place at the Sheraton Boston, Boston, MA, on October 18-19, 2023. Meet Us at…
Explore the intricate paths of regulatory compliance, with a focus on IDMP and SPOR, their implementation, and the urgency for proactive action.
Ennov is honored to sponsor the Global Pharmaceutical Regulatory Affairs Summit, a hybrid event taking place at the DoubleTree by Hilton, Brussels, from October 23-25, 2023. Accelerating Pharmaceutical Compliance with…
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% of organizations are already actively…
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 Medicines Agency (EMA) stand out…
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 to consider the transformative shifts…
Ennov is thrilled to announce our participation at RAPS Convergence 2023, the largest and most well-recognized annual gathering of global regulatory affairs professionals. The event will be hosted at the…
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 authoritative approach. The challenge lies…
Ennov is excited to announce our participation in the 2023 CDISC TMF Interchange, a new annual conference dedicated to the TMF Reference Model Initiative and more, taking place at the…
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 mandated submission format for…
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 agile tech stacks to challenge…
How are you going to be ready for IDMP compliance? Ennov has the answer.
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 and challenges. Here are the…
Webinaire QMS, les limites de la pré-validation par l’éditeur Il est tentant d’imaginer qu’utiliser un Core Model éditeur permet de s’affranchir de la validation. Le doute est permis.7 juillet 2023…
Are you looking for a transformative solution to streamline your PV processes without compromising compliance?
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 enables medical device companies to…
Webinaire Bonnes Pratiques Qualité : qui doit décider, du logiciel ou de vos pratiques ? Adopter le modèle prêt à l’emploi de l’éditeur est une approche intéressante. Est-elle réaliste ?mardi…
Webinar Introducing Ennov's Agnostic Solution for IDMP, the EASI connector How are you going to be ready for IDMP compliance? Ennov has the answer.June 21st at 11:00 AM – 11:30…
Ennov is set to exhibit at the 2023 DIA Global Annual Meeting, taking place June 25-29 in Boston, MA. Be sure to visit us booth #424! The DIA Global Annual…
Are you looking to maximize the efficiency of your electronic Trial Master File (eTMF) while minimizing effort and risk? Look no further! Our webinar is designed to provide you with…
Manage safety signals and demonstrate a robust approach to signal detection with a searchable repository and workflow-driven solution.
Ensure veterinary safety with a flexible & compliant pharmacovigilance (PV) software. Manage data easily, meet critical reporting deadlines.
Ensure patient safety with Ennov PV-Works, the comprehensive pharmacovigilance software that streamlines adverse event management, reporting.
Efficiently detect potential signals with Ennov PV-Analyzer. A feature-rich, easy-to-use statistical analysis tool for pharmacovigilance.
An observation is said to be censored in time when the event of interest cannot be observed at the time at which the analysis isconducted. Special cases are right censoring…
The evaluation of the likelihood that a medicine was the causative agent of an observed adverse event in a specific individual. Causality assessment is usually made according to established algorithms.…
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.Source: ICH Guideline E6: Good Clinical…
A person who helps a patient with daily activities, healthcare, or other activities that the patient is unable to perform because of age, illness or disability, and who understands the…
A study that evaluates the association of specific genetic variants with outcomes or traits of interest, selecting the variants to be tested according to explicit considerations (known or postulated biology…
Samarind Strengthens Ennov’s global position in the RIM for Medical Devices and its presence in the UK market Ennov, a leading provider of regulated content and data management software for…
Pharmacovigilance Webinar PV Made Simple: Discover a Fully Compliant AND Affordable Solution in Just 30 Minutes Streamline processes and break down silos to reduce time to market! Wednesday, May 31st,…
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 for Quality Management System Software…
Maximize your regulatory team's potential with a right-sized RIM. Learn how SMBs can bring products to market faster with fewer resources.
Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.
Efficiently manage and share documents with Ennov Doc. Metadata-based document model, efficient search capabilities, intuitive interface.
Efficiently manage clinical trials with Ennov CTMS. Unified platform, pre-integrated with eTMF and EDC, customizable workflows.
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
Simplify Clinical Data Collection with Ennov EDC. Configurable edit checks, allowable values library, and pre-integrated with eTMF and CTMS.
The additional load that a clinical activity imposes on patients above that which would be experienced under normal clinical practice. Source: (CIOMS XI: Patient involvement 2022)
Burden is defined as the additional load that a risk minimisation activity imposes on (1) patients, (2) carers, (3) the healthcare system including health care professionals, (4) others such as…
A warning that appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks. Not all health authorities implement boxed warnings in the label,…
Learn how master data management impacts regulatory affairs. Explore the importance of RIM and IDMP integration for data quality, compliance.
Effortlessly manage clinical trial documentation with Ennov eTMF. Centralized repository, intelligent automation, and real-time dashboards.
Streamline Your Business Processes with Ennov Process BPMS. Automate, ensure compliance and increase efficiency.
Streamline Training with a Learning Management System. Simplify compliance monitoring, evaluate staff proficiency, automate onboarding.
Ennov will be sponsoring and exhibiting at the RAPS Euro Convergence 2023 conference from May 10-12, 2023 at the Park Inn by Radisson Amsterdam City West in Amsterdam, The Netherlands. …
A correction to allow for the probability of many events that are independent, named after Carlo Emilio Bonferroni (1892-1960). In statistical significance testing, it allows, for example, 10 different significance…
A measured characteristic of either normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers.…
An analysis involving only two categories (e.g., baseline vs final values, in contrast to analysis of multiple values from continuous measurements, as for a progression of laboratory values). The latter…
Bayesian confidence propagation neural network (BCPNN) Empirical Bayesian algorithm used for signal detection in spontaneous report databases.Source: (CIOMS VIII: Signal detection 2010)
A theorem in probability named after Reverend Thomas Bayes (1702-1761). It is used to refer to a philosophy of statistics that treats probability statements as having degrees of belief, in…
Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be initially similar between groups; if…
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