News & Events
RIM Analytics: Dashboards with a Purpose
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 deliberate and data-driven, and activity management is holistic. What do all of these RIM activities
Brexit Lingers on in the RIM World
“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.”
Regulatory Webinar: Ennov Dashboards in Action: Visualize Your Regulatory Risk and Status
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Gartner market Guide for Life Science Regulatory Information Management Solutions
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 complex needs of regulatory affairs and operations. Life science CIOs
Four Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management (RIM) system, they might say to provide replacement for spreadsheets, consolidate regulatory information in one place, or to enable tracking and management of approvals. They might
FDA News: FDA Updates Various eCTD Documents
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 supporting documents. Support for Modeling and Simulation. This is an
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
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 31 March 2019. The report provides excellent insight into MHRA’s
Gartner: Hype Cycle for Life Science Research and Development, 2020
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 Hype Cycle to select technologies and identify innovations to build
FDA Removes Two-Way Communication from eCTD 4.0
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 two components: CTD v4.0 Technical Conformance Guide (PDF) FDA eCTD v4.0
RIM Webinar: Accelerate Time to Value by Leveraging Predefined Regulatory Processes
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 the inherent inefficiency of traditional workshop-driven requirements analysis and system