Introducing Ennov 10.3
We are thrilled to announce the release of Ennov 10.3, delivering even greater satisfaction to our platform's users. This latest version introduces two significant new features: Enhanced AI Capabilities Ennov…
Product Management Service (PMS)
The Product Management Service (PMS) is a core element of the European Medicines Agency's (EMA) IDMP implementation. PMS provides a centralized, standardized database for managing medicinal product information across the…
Is Your Portfolio Ready for Data Enrichment?
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 into the e-Application Form (eAF). …
Aligning RIM and PMS: Challenges for a Systematic Comparison
Discover essential strategies in this informative session with Ennov’s own Pierre Stanislawski and Maxime Delpire, as they dive into the challenges of aligning RIM and PMS data. Learn about the…
IDMP at the EMA: The European Shortage Monitoring Platform
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 IDMP implementation yet with the…
Global eCTD Regulatory Updates
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
Ennov and CognifAI Partner for AI-Driven Pharmacovigilance
Ennov, a leading provider of unified compliance software solutions for the Life Sciences, is pleased to announce a strategic partnership with CognifAI, an innovative AI solutions company specializing in pharmacovigilance.…
Ennov to Sponsor the 2024 Global Pharmaceutical Regulatory Affairs Summit
Ennov is excited to announce its sponsorship of the 2024 Global Pharmaceutical Regulatory Affairs Summit (GPRAS), a hybrid event taking place from October 22-24, 2024, at the Sheraton Brussels Airport,…
Why The Future of Pharma Starts with IDMP
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…
Ennov to Exhibit at ICTMC 2024
Ennov will exhibit at the 7th International Clinical Trials Methodology Conference (ICTMC) 2024, being held from September 30 to October 3 at the EICC in Edinburgh, UK. At ICTMC 2024,…
Preparing for eCTD 4.0 Pilots
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 and collaboration we ensure that…
Ennov to Exhibit at RAPS Convergence 2024
Ennov is excited to announce our participation at RAPS Convergence 2024, the largest and most well-recognized annual gathering of global regulatory affairs professionals. This year, the event will take place…
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
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…
Transforming Regulatory Affairs for a Biopharma Leader
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…
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
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…
Ennov RIM for Med Device
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 Completes the Enterprise Technology Integration from Calyx
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…
Future-Proofing Quality Management: A Guide for SMBs in Life Sciences
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…
Gartner Insights: Maximize Your QMS Success with Peer Guidance
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 to Exhibit at the 2024 DIA Global Annual Meeting, June 16-20 in San Diego, CA
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…
Compliance Without Compromise: Med Device Edition
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…
How to Future-Proof MedDevice/MedTech Compliance
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 to Sponsor the 2024 CDISC + TMF Europe Interchange
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 to Sponsor the Pronovea Pharma Summit 2024
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…
AI in Quality Management with ION Pharma
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…
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
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…
AI and Its Impact on Life Sciences
Discover how Generative AI is revolutionizing drug development, healthcare, and regulatory compliance, shaping the future of the industry.
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic 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.…
Artificial Intelligence (AI)
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.
Why Unified Platforms are the Future of Cosmetovigilance
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…
AI-Driven Cosmetovigilance Solution for the Global Leader in Luxury
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…
Dermatological Safety Assurance with Unified Platforms
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…
Ennov Announces Strategic Acquisition of Calyx’s ‘Enterprise Technology’ Division
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…
Ennov Boosts Portfolio with Acquisition of DocShifter: The Market-Leading Document Transformation Solution
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 New Wave of QMS [8/8]: Reflections & Looking Ahead
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…
Unified Quality and Regulatory Information Management
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
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The New Wave of QMS [7/8]: Cybersecurity Measures
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 New Wave of QMS [6/8]: Flexibility & Adaptability
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 New Wave of QMS [5/8]: User-Centric Interface
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…
The Trust Equation: Safety, Branding, and Consumer Loyalty
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 to Sponsor the 2024 DIA RSIDM Forum
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…
Holistic Beauty and Safety Compliance: Bridging the Gap
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…
Sustainability in Safety: The Cosmetovigilance Approach
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,…
Streamlining Operations with Digital Cosmetovigilance
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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The New Wave of QMS [4/8]: Data-Driven Decisions
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…
Case Study: Pharmacosmos
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
Ennov’s Medical Device Working Group Unites Industry Leaders
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…
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
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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The New Wave of QMS [3/8]: Scalability
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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The New Wave of QMS [2/8]: Comprehensive Integration
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…
Strategic Safety Data Management for Cosmetic Compliance
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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The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
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…
Regulatory Compliance in the Cosmetics Industry
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,…
IDMP without Data Re-entry
Join us on a journey to discover the key strategies for streamlining IDMP compliance without the burden of data re-entry.
Navigate PV Safety with Confidence, Gain Instant Insights, and Take Action!
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?…
Ennov to Sponsor 9th Annual European Drug Safety Pharma & Biotech Conference
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.…
IDMP: What’s Different This Time?
Tune in to gain insights from industry experts as they unpack the challenges and opportunities lying ahead for IDMP.
The RAP Up: Trends from 2023 RAPS Convergence
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 Forms Strategic Partnership with ION Pharma to Elevate Quality Management in Life Sciences
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 to Exhibit at the World Drug Safety Congress Americas 2023
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…
Navigating The Regulatory Landscape: The Ultimate Guide to Your IDMP Journey
Explore the intricate paths of regulatory compliance, with a focus on IDMP and SPOR, their implementation, and the urgency for proactive action.
Ennov to Sponsor Global Pharmaceutical Regulatory Affairs Summit
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: The Time is Now
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 Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
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 to Exhibit at RAPS Convergence 2023
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…
Gartner Insights: IDMP & EMA Compliance
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 to Attend 2023 CDISC TMF Interchange
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…
Best Practices: Cross-Referencing in eCTD
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…
Empowering Emerging Pharma Organizations through DLSP Strategy
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…
Ennov’s Agnostic Solution for IDMP, the EASI connector
How are you going to be ready for IDMP compliance? Ennov has the answer.
Top 5 Trends in Life Sciences in 2023: Driving the Future of Innovation
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…
PV Made Simple
Are you looking for a transformative solution to streamline your PV processes without compromising compliance?
Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
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…
Ennov’s Agnostic Solution for IDMP, the EASI connector
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 to Exhibit at the 2023 DIA Global Annual Meeting, June 25-29 in Boston, MA
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…
Streamlining your eTMF: 10 Best Practices for Reducing Both Effort and Risk
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…
PV-Signal Manager
Manage safety signals and demonstrate a robust approach to signal detection with a searchable repository and workflow-driven solution.
PV-Works Vet
Ensure veterinary safety with a flexible & compliant pharmacovigilance (PV) software. Manage data easily, meet critical reporting deadlines.
PV-Works Human
Ensure patient safety with Ennov PV-Works, the comprehensive pharmacovigilance software that streamlines adverse event management, reporting.
PV-Analyzer
Efficiently detect potential signals with Ennov PV-Analyzer. A feature-rich, easy-to-use statistical analysis tool for pharmacovigilance.
Censored/Censoring of Data
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…
Causality assessment
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.…
Case report form (CRF)
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…
Caregiver
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…
Candidate gene study
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…
Ennov Acquires RIM Solution Provider Samarind
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…
PV Made Simple | Pharmacovigilance Webinar
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,…
Empower Your Quality Management Journey with Gartner Market Guide Insights
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…
Why SMBs should choose a right-sized RIM
Maximize your regulatory team's potential with a right-sized RIM. Learn how SMBs can bring products to market faster with fewer resources.
Ennov Dossier
Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.
Ennov Doc
Efficiently manage and share documents with Ennov Doc. Metadata-based document model, efficient search capabilities, intuitive interface.
Ennov CTMS
Efficiently manage clinical trials with Ennov CTMS. Unified platform, pre-integrated with eTMF and EDC, customizable workflows.
Ennov Doc for Regulatory
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
Ennov EDC
Simplify Clinical Data Collection with Ennov EDC. Configurable edit checks, allowable values library, and pre-integrated with eTMF and CTMS.
Burden to patients
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 of a risk minimisation activity
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…
Boxed warning (“black box warning”)
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,…
Best Practices: Master Data Management
Learn how master data management impacts regulatory affairs. Explore the importance of RIM and IDMP integration for data quality, compliance.
Ennov eTMF
Effortlessly manage clinical trial documentation with Ennov eTMF. Centralized repository, intelligent automation, and real-time dashboards.
Ennov Process
Streamline Your Business Processes with Ennov Process BPMS. Automate, ensure compliance and increase efficiency.
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