Core Data Sheet is an unofficial working document prepared by marketing authorization holders typically containing material relating to safety, indications, dosing, pharmacology, and other information concerning the product. Source: Law…
In the EU, other countries that review the Application during or after the Reference Member State review.
[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated application that must be satisfactorily…
A medicine's regulatory authority in the European Union. Source: EMA Glossary
The Common Technical Document (CTD) is a format for marketing applications submitted to ICH participating regions, controlling the organization of information in an application.
"The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. The CHMP plays a vital role in the authorisation of…
"Activities to be performed by or on behalf of a Party or its Affiliates as a condition or in connection with receipt of Regulatory Approval of a Licensed Product in…
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the United States…
See Manufacturing Supplement. [FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in the manufacturing…
[FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in the manufacturing of the product…
"In the EU, individual member states review and approve individual applications to run clinical trials within that country. One application is submitted for each clinical trial protocol in each country…
The Clinical Data Interchange Standards Consortium is a standards developing organization dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related…
That part of pharmaceutical development that deals with the nature of the drug substance and drug product, the manner in which both are made, and the manner by which the…
Chemical Abstracts Service (CAS) Number: A unique accession number assigned by the Chemical Abstracts Service, a division of the American Chemical Society. Other than being guaranteed unique to a given…
A checksum is a sequence of numbers and letters used to check data for errors. If the checksum of an original file is known, an algorithm can be used to…
Certificate of Suitability to the monographs of the European Pharmacopoeia. A certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid…
Another term for Centralised Procedure (CP). "An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs,…
"An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs, such as biotech, HIV, cancer and…
The Center for Drugs Evaluation and Research (CDER) is the division of FDA that is responsible for the licensing and regulation of pharmaceuticals (with the exception of biologics).
FDA Division that assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Source: FDA
The Center for Biologics Evaluation and Research (CBER) is the division of FDA that is responsible for the licensing and regulation of biologic drug products. These are pharmaceuticals that have…
Authorisation in the European Economic Area (EEA) for the marketing and sale of devices, and specifically within Life Sciences, Medical Devices.
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health in…
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. Source: FDA
[FDA] FDA: A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of…
This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted…
[FDA] A written communication to an applicant from FDA approving an application or an abbreviated application. Source: 21 CFR 314.3(b)
The identifier assigned to an application by a Health Authority. Source:
"A pharmaceutical company or its agent that is submitting information in support of an application." Source: Harmonised Technical Guidance for eCTD Submissions in the EU
[FDA] Post-NDA report (submission) providing the FDA with a summary of new research data, distribution information and labeling changes plus certain other information form manufacturers. These reports must be filed…
"Annotated ECG waveform data are raw voltage-versus-time data comprising the electrocardiogram recording, to which have been attached the identification of various intervals or other features." Source: Study Data Specifications (FDA)
An annotated case report form (CRF) is a blank CRF with annotations that document the location of the data with the corresponding names of the datasets and the names of…
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,…
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,…
“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.”
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…
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,…
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 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.
Implementing an electronic document, business process and training management solution to increase efficiency across the organization.