WebMar 31, 2024 · The Clinical Trials Regulation requires all information stored in the CTIS database to be publicly available, unless exempted to protect the following:. Personal data; Commercially confidential information (in particular the marketing-authorisation status of a medicine, unless there is an overriding public interest); Confidential communication … WebAug 2, 2024 · CTIS is part of an information toolkit that EMA will use to achieve a more coordinated approach to clinical trial safety reporting; implementation of the Clinical Trials Regulation will eventually result in “substantial changes” in how clinical trials are authorized, and how human research is conducted and supervised within the EU.
CTIS set to launch in EU; sponsor guide now online RAPS
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WebJan 31, 2024 · EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union (EU)/European Economic Area (EEA) from 1 May 2004 until 30 January 2024 under Directive … WebThe Clinical Trials Information System (CTIS) supports the flow of information between … European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The … WebThe most critical features in military applications are reliability and performance. Our industry-proven Spicer ® Central Tire Inflation System (CTIS) for the military vehicle is designed to enhance government defense vehicles with significantly improved all-wheel drive performance, maximum mobility, and full diagnostics.. A “limp home” feature … howard hamlin mcgill