WebJan 31, 2024 · The Clinical Trials Information System (CTIS) supports the business processes of clinical trial sponsors and national regulators throughout the lifecycle of a clinical trial, via secure workspaces. On this page you will find some basic questions about the use of CTIS. You can also browse the topics below to find what you are looking for. … WebFeb 15, 2024 · A well-planned and detailed training programme on CTIS has been initiated by the EMA, in order to prepare all the end-users ahead of its launch. The CTIS training material is also tailored in various modules for different …
Clinical Trials Regulation & CTIS - fimea englanti
WebThe Clinical Trials Information System (CTIS) contains the centralised EU portal and database for clinical trials foreseen by the CTR. CTIS is the single entry point for submitting the clinical trial application in the EU. WebFor more information on training and support for the use of CTIS is available on EMA's CTIS training and support page. EMA's modular training program page contains information and training on the functionalities of CTIS. CTIS Sponsor Handbook. CTIS newsletters. More information on the Clinical Trials Regulation, visit Eudralex – Volume … the myerson law group
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WebMar 4, 2024 · Training is available from the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS) ahead of its planned launch. EMA’s training resources are tailored for clinical trial sponsors and staff of the European Union (EU) Member States, European Commission and other organisations who will use the … WebThe European Medicines Agency’s (EMA) Service Desk provides a dedicated, online helpdesk for clinical trial sponsors and regulators requiring technical support with using … WebThe sponsor workspace in the Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organisations involved in running clinical trials in preparing and compiling clinical trial applications and dossiers to submit for assessment by Member States in the European Union (EU) and European Economic Area (EEA). how to display a sword