The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted classification system for medicines that is maintained by the World Health Organisation (WHO). The WHO assigns ATC codes to all…
Analysis datasets are datasets created to support results presented in study reports, the ISS and the ISE and to support other analyses that enable a thorough regulatory review. Analysis datasets…
ADaM defines dataset and metadata standards that support efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data, and data represented in the…
"[FDA] Information submitted to a pending submission, including additional information or reanalysis of data previously submitted to clarify, revise or modify the application as originally submitted. Major Amendment - an…
An ingredient in a medicine that increases or modifies the activity of the other ingredients. Adjuvants are often included in vaccines to enhance the body’s immune response. Source: EMA Glossary
Documentation providing detailed information on the manufacturing of the active substance of a medicine. Source: Electronic Active Substance Master Files (eASMF)
[FDA] [An] active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure…
The substance responsible for the activity of a medicine. See Drug Stubstance.
Active Pharmaceutical Ingredients (API) refers to an active ingredient that is contained in the medication. See Drug Stubstance.
Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the results of clinical trials. An…
An ANDA (ANDA) is an abbreviated version of an New Drug Application (NDA). It is allowed for duplicates of drug products that were first approved before October 10, 1962 and…
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients. Adverse Drug Reaction: The detection, assessment, understanding and prevention of ADR are…
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies,…
Interoperable structured data is increasingly burdensome for pharmaceutical companies. This white paper examines some real examples of interoperable structured data and provides some recommendations to prepare for future changes.
Dendreon selected Ennov Regulatory Suite to implement a cloud-based, unified electronic document management, publishing, and regulatory information management (RIM) software system to manage regulatory documents, publishing and product registrations, as…
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 this blog article, I look…
Ennov is pleased to announce that we are sponsoring the Trial Master File Summit being held at the Roosevelt Hotel in New Orleans, LA on May 2-4, 2022. This year’s…
Ennov, the provider of the only unified compliance platform for Life Sciences – a highly configurable software architecture that provides a consistent user experience and eliminates data silos –, has…
Ennov, a leading provider of innovative software solutions for the Life Sciences industry is pleased to announce the release of Version 9.3 of its unified compliance platform. This release introduces…
Ennov is pleased to announce its sponsorship for the 2022 Global Pharmaceutical Regulatory Affairs Summit (GPRAS) being held in Berlin on April 6-8, 2022. In addition to the on-site event,…
Ennov is deeply concerned about the situation in Ukraine and is closely following the humanitarian crisis unfolding there. Although we have no direct activity in Ukraine, we are very aware…
Ennov, a leading provider of innovative software solutions for the Life Sciences industries is pleased to announce the opening of a new office in Saint Joseph, Missouri. The new office…
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 regulatory information in one place,…
Ennov is pleased to announce its participation and sponsorship at the 10th edition of the AFCROs (French Association of CROs) Clinical Research Day being held at the Hyatt Regency Etoile…
Ennov is pleased to announce that we will be exhibiting at the 2022 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum being held at the Bethesda North Marriott Hotel…
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 in almost all of their…
This QMS project had two major objectives: ensure the safety of patients and staff, as well as foolproof reliability.
Ennov is pleased to announce its participation in the 6th European Conference on Clinical Research. This hybrid conference will have a digital presence as well as an in-person event at…
This paper will examine the KPIs of Completeness, Quality and Timeliness in more detail in order to assist organizations in improving the quality and understanding of these metrics and their roles in risk management, continuous process improvement, and compliance.
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 from Version 2.1 of 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 latest news in the RIMS…
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 latest news in the RIMS…
As the industry continues to move towards structured data, the compliance requirements of RIM systems will only increase.
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 latest news in the RIMS…
Ennov, a leading provider of innovative software solutions for the Life Sciences industries is pleased to announce the opening of a new office in Hanoi, Vietnam. Together with the European…
Risk-based clinical quality may require information from: the CTMS and eTMF, but also from the EDC, ePRO, RTS, RIMS, and QMS.
Ennov’s Partnership with Pharma IT provides a full pharma-focused solution that responds with a single repository platform.
Ennov is pleased to announce that we are sponsoring the 10th annual Trial Master File Summit being held at the Roosevelt Hotel in New Orleans, LA on October 25-27, 2021.…
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 the information – everyone tries…
Bachem Americas Inc. needed to identify a partner with a flexible solution that could meet their specific needs for a RIM solution.
Ennov’s strategic customer Boehringer Ingelheim selected the Ennov RIM as a global Regulatory Information Management (RIM) system for their Animal Health and Human Health businesses. The first major milestone was…
September 27-29, 2021 in Philadelphia, PA Ennov is pleased to announce that we are sponsoring the Clinical Quality Oversight Forum being held at the Hilton Philadelphia City Line Avenue Hotel…
Ennov is Recognized in 5 Different Technology Areas Ennov today announced it has been recognized five times by Gartner as a vendor in the 2021 “Hype Cycle for Life Science…
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 provides recommendations for sponsors to…
30 minutes to learn how to improve the quality and timeliness of your studies requiring more patients and centers especially in the COVID context. Tuesday July 20 from 2:00pm (CEST)…
As per Gartner, “Poor data quality, disjointed solutions and siloed regulatory business processes delay life science companies’ entry into new markets. This research illuminates the current state of regulatory technology,…
This webinar showcases one of our newest products - Ennov Analytics, our powerful yet easy-to-use reporting and data visualization software. This presentation focuses on its use in conjunction with Ennov CTMS, our highly capable Clinical Trial Management solution.
Learn how Ennov Analytics frees you from data gathering and spreadsheet manipulation by providing targeted dashboards where you can complete a precise analysis with just a few clicks.
Learn how to decrease the time required to implement Regulatory Information Management systems using a streamlined approach.
“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.”
Learn how PV-Analyzer can help prepare statistical detailed analyses of safety data to reduce risk
Tuesday, 20 April 2021 11:00AM EDT | 5:00PM CEST Encouraged by Health Authorities, many life sciences companies have adopted risk-based approaches throughout the organization. But effective risk management programs require…
Ennov gives you complimentary access to : “Gartner Market Guide for Life Science Regulatory Information Management Solutions” As per Gartner,”Regulatory information management vendors offer new solutions to manage the increasingly…
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 change history and links to…
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period from 1 April 2018 to…
Ennov gives you complimentary access to Gartner's report: "Hype Cycle for Life Science Research and Development, 2020*" This Gartner Hype Cycle is a reference for Life Science CEOs."Use this…
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 issued without comment, and includes…
Tuesday February 16, 2021 - 11:00 AM EST | 5:00 PM CET Join our free webinar to learn the benefits of leveraging our library of predefined Regulatory processes that address…
Learn how Ennov Analytics Dashboards are used to manage risk, increase efficiency and improve insight.
Ennov is pleased to announce the launch of the Ennov Insider – a new, exclusive library of premium content available only to registered users. The Ennov Insider contains white papers,…
Learn how Ennov RIM and Documentum can operate effectively together in an enterprise system architecture.
Learn how Ennov RIM and Ennov PV are used to enable the efficient production of Periodic Safety Update Reports
Ennov are pleased to announce that the Danish pharmaceutical company Pharmacosmos has implemented Ennov Doc and Ennov Training for the management of their global Quality and GxP documentation. Following the…
Ennov is pleased to announce the addition of Steve Clark to our team of Regulatory experts. Steve has over 20 years of global Regulatory operations experience that he gained at…
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, communicate and take action on…
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 believe that a quality system…
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, and solutions. One of the…
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 and has been revised with…
Learn how Ennov RIM enables the effective management of CMC variation change controls.
Learn best practices for migrating documents from legacy systems into Ennov.
Learn how Ennov CTMS and eTMF enables planning, management, documenting of clinical trials.
Learn how Ennov RIM enables the management and submission of XEVMPD information to the EMA.
Learn how Ennov enables compliance with the US FDA's 21 CFR Part 11 guidance.
Learn about the interactions between eDMS and IDMP to gain insights into the best practices regarding data governance and IDMP compliance.
Learn how Ennov Doc's integration with Office 365 drives innovation through collaborative authoring.
Learn the key areas where a unified CTMS and eTMF can result in the greatest benefit.
Learn why effective management of Clinical CAPAs is key to operating in a state of control.
Learn why an optimized TMF strategy is essential to maintaining inspection readiness and reducing risk.
Learn how Vetoquinol implemented Ennov Doc and Ennov QMS to reduce compliance risk and improve performance.
Implementing an electronic document, business process and training management solution to increase efficiency across the organization.
Utilizing Ennov PV to drive drug safety outsourcing services to pharmaceutical companies.
Leveraging Ennov Clinical to transform business by delivering Clinical data management services and increasing revenue.
Aligning regulatory activities to strengthen competitive position.
Ennov announces its inclusion in the “2020 World Class RIM Whitepaper; Is Industry at a Performance Tipping Point”, published by Gens & Associates, a leading independent consultancy specializing in strategic…
Ennov announces its inclusion in the 2020 “Market Guide for Quality Management System Software”, published by Gartner, Inc., the leading information technology research and advisory company. According to Gartner, “The…
Synairgen has selected Ennov PV to support the conduct of a clinical trial of SNG001 in patients with COVID-19. Synairgen will be using the Ennov PV Works solution to collect,…
Ennov, a leading provider of innovative software solutions for the Life Sciences industry is pleased to announce the release of Version 8.6 of our unified compliance platform. The release includes…
Join our free webinar to learn how fme Life Sciences and Ennov are working together to mitigate the data migration risks associated with Regulatory Information Management (RIM) implementations. We will…
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 supplements during a pandemic. FDA…
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 excellent information not previously available…
Ennov is pleased to announce that we will be exhibiting at the 2020 Global Pharmaceutical Regulatory Affairs Summit (GPRAS) being held at the Berlin Hotel Palace on April 21-23, 2020.…
fme Life Sciences to offer enterprise content and data management services in support of Ennov’s Regulatory solution suite. Ennov and global professional services firm fme Life Sciences are pleased to…
Ennov is pleased to announce that we will be exhibiting at the 2020 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum being held at the Bethesda North Marriott Hotel…
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 11, Issue 11). I wanted…
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 submit a single submission in…
Ennov is pleased to announce that we are sponsoring the 9th Trial Master File Summit and CROWN Congress being held at the Sheraton Lake Buena Vista Hotel in Orlando, FL…
Dec 10th at 11 AM – 11:30 AM PST | 2 PM – 2:30 PM EST With the increasing complexity of the global regulatory landscape, Regulatory Information Management (RIM) is…
Ennov announces its inclusion in four 2019 Life Science market research reports published by Gartner, Inc. the leading information technology research and advisory company. The following reports recognize Ennov solutions:…
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 big, well-known EDC providers, to…
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