• May 2022: Clinical Trials Regulation Update - European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment‘ document over the What’s New Section on May 20, 2022: Under the Accelerating Clinical Trials European Union (ACT EU) initiative EMA created a new page to publish reports that include … Continue reading "May 2022: Clinical Trials Regulation Update"
  • May 2022: CTIS Update - European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application over the What’s New Section on May 18, 2022. It notifies that ‘CTIS bitesize talk: Transitional trials and additional MSC application‘ event will be held on June 23, 2022. The sponsors … Continue reading "May 2022: CTIS Update"
  • May 2022: CTIS Update - European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) bitesize talk: Modifications over the What’s New Section on May 11, 2022. It notifies that CTIS bitesize talk: Modifications event will be held on May 31, 2022. The sponsors will get an opportunity to learn about the modifications that can be made … Continue reading "May 2022: CTIS Update"
  • May 2022: What’s New on ClinicalTrials.gov PRS Beta Test System - The below update was posted on the What’s New section of ClinicalTrials.gov PRS Beta test system, which will be available on ClinicalTrials.gov PRS Beta by late May, 2022: The following updates, improvements, and bug fixes were made in the different section of the PRS Beta test system Record List Page The release version number was … Continue reading "May 2022: What’s New on ClinicalTrials.gov PRS Beta Test System"
  • May 2022: CTIS Update - European Medicines Agency updated the event page Clinical Trials Information System (CTIS): Walk-in clinic over the What’s New Section on May 06, 2022: The update notifies that the video recording of the walk-in clinic held on March 28, 2022, is now available on the event page. Walk-in clinics provide a platform for sponsors to receive … Continue reading "May 2022: CTIS Update"
  • May 2022: CTIS Training Update - European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on May 04, 2022, by updating the below documents in Module 02- High-level overview of CTIS workspaces and common system functionalities and Module 03- User access management: Clinical Trials Information System (CTIS) common features – Module 02 (v1.3): Updated the name … Continue reading "May 2022: CTIS Training Update"
  • May 2022: CTIS Update - European Medicines Agency updated about the upcoming Clinical Trials Information System (CTIS): Walk-in clinic events over the What’s New Section on May 03, 2022: The event CTIS: Walk-in clinic will be conducted on the following dates: June 02, 2022: 16.00 to 16.45 (CEST) June 15, 2022: 15.00 to 15.45 (CEST) Walk-in clinics will be conducted … Continue reading "May 2022: CTIS Update"
  • April 2022: Netherlands Update - Performance studies on in vitro diagnostics (IVDR) On 26 May 2022, the EU Regulation on Medical Devices for In Vitro Diagnostics, also known as the In Vitro Diagnostics Regulation (EU no 2017/746, IVDR) will come into effect. The IVDR contains specific rules for the submission, assessment and execution of performance studies on in vitro diagnostics, IVDs. On … Continue reading "April 2022: Netherlands Update"
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