EMA’s IT Systems Unavailable 24 Hours This Weekend
All the IT systems of the European Medicines Agency (EMA) will be temporarily unavailable from 6 am U.K. time on Saturday, April 16 to 6 am Sunday the 17th (U.K. time) due to essential maintenance, according to an EMA announcement released yesterday.
All the IT systems of the European Medicines Agency (EMA) will be temporarily unavailable from 6 am U.K. time on Saturday, April 16 to 6 am Sunday the 17th (U.K. time) due to essential maintenance, according to an EMA announcement released yesterday.
“During these 24 hours, it will not be possible to access the EMA public website, or any other EMA-hosted website or online application, including the systems used to send and receive applications for EMA regulatory procedures. Normal service will resume on April 17,” the agency noted.
Emails sent to EMA email addresses during this period will be queued and delivered to recipients on the 17th. The EMA product emergency hotline and phone number for notifying suspected quality defects or product recalls will operate as usual. While the EMA public website is unavailable, a holding page will be displayed with details of these emergency numbers.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
