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- Reporting safety information on - European Medicines Agency (EMA)
For clinical trials authorised under the Clinical Trials Directive, sponsors must report the information below for assessment by the relevant EU and EEA authorities For SUSARs, they should report to EudraVigilance
- Guidance and Q As - EMA
What is CTIS? The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorisation and supervision of clinical trials in the European Union and the European Economic Area You can find more information on CTIS on our About page Do I need to use CTIS?
- EU CTIS: Europe’s New Clinical Trial Information System - Certara
The EU CTIS (Clinical Trial Information System) has launched and as of January 31, 2025, CTIS EU is the single-entry point for submitting, assessing, authorizing, supervising, and reporting clinical trials in all EU Member States
- Information on CTIS and Clinical Trials Regulation (EU) 536 2014
CTIS is the only way to send information about clinical trials in the EU and EEA from January 31st 2023 CTIS is a workspace for clinical trial sponsors and for competent authorities, and also a clinical trial public website
- What Is CTIS Compliance and Why It Matters for Clinical Trials in . . .
CTIS compliance refers to the requirement for clinical trial sponsors to use the Clinical Trials Information System (CTIS)—the European Union’s centralized platform—for submitting, managing, and reporting clinical trials under the EU Clinical Trial Regulation (CTR 536 2014)
- EU Clinical Trial Regulation 536 2014 and CTIS: FAQ - QPS
The CTIS is a centralized database developed by the European Medicines Agency (EMA) to support the implementation of the EU CTR It serves as a single-entry point for the submission, assessment, and supervision of clinical trial applications within the EU
- CTIS Explained: Insights and Best Practices for Clinical Trials
What is the Clinical Trial Information System (CTIS) and why is it essential? The Clinical Trial Information System (CTIS) is a centralized platform introduced by the European Medicines Agency (EMA) under the EU Clinical Trial Regulation (Regulation (EU) No 536 2014)
- All about CTIS and whats in it for medical writers
What is the Clinical Trial Information System - CTIS? It is a common workspace for all aspects of clinical trial approval, maintenance, and results reporting in the EU EEA The use of CTIS is mandatory for all clinical trials with a trial site in the European Union and the European Economic Area (EU EEA)
- Understanding The Basics Of EU Clinical Trials With CTIS
Clinical Trials Information System (CTIS) streamlines the process for evaluating and overseeing clinical trials across the EU A unified clinical trial application (CTA) with a core dossier is submitted for approval, reaching all European national competent authorities and ethics committees and ensuring the trial is registered in a public database
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