News & Events
Smart Signal Management in Pharmacovigilance
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 potential PV risks, as needed. You have identified a signal…Now
Clinical CAPAs: Are Your Trials in a State of Control?
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 is not in a state of control. During inspection, we
Preparing for IDMP: Insights from the Gens & Associates survey
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 six stated goals of the study was specifically to “Quantify
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
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 This draft guidance was first issued in 2018 and has been revised with industry comments. Section 303(f)(3) of the Federal Food, Drug, and
Synairgen Selects Ennov PV to Support COVID-19 Clinical Trial
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, manage and report clinical safety data associated with the trial.
Ennov Announces the Release of Version 8.6 with Full XEVMPD Support
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 many new features and functions including enhancements to Ennov Doc,
Webinar: Mastering The Challenges of RIM Data Migration
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 discuss the many challenges faced by companies faced during RIM
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
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 anticipates that during a pandemic, industry and FDA workforces may
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
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 in any published form. It covers notification, planning, conduct, documentation, system
Ennov to present the latest version of its game-changing RIM at the 2020 Global Pharmaceutical Regulatory Affairs Summit, Berlin, April 21-23
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. We will present the latest version of our game-changing RIM,