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Um klinische Prüfungen, die zuvor im Rahmen der EU-Richtlinie über klinische Prüfungen genehmigt wurden, erfolgreich auf das EU-Informationssystem für klinische Prüfungen (CTIS) umzustellen, müssen die Sponsoren mehrere wesentliche Vorbereitungsmaßnahmen ergreifen. Diese Vorbereitungsschritte können umfangreich sein und werden oft missverstanden, was die Notwendigkeit einer gründlichen Vorbereitung unterstreicht. Erste Vorbereitungen Beginnen Sie damit, sicherzustellen, dass Sie über eine Erklärung [...]

The implementation of the Clinical Trials Regulation (CTR) has introduced additional complexities for non-EU sponsors, particularly concerning the obligations of the legal representative. Non-EU sponsors are mandated to appoint an EU-based legal representative to ensure compliance with CTR standards. While the requirement for a legal representative is not new, the CTR explicitly tasks them with

The European Medicines Agency (EMA) offers a pivotal advantage to Small and Medium-Sized Enterprises (SMEs) engaged in the development of medicinal products for both human and veterinary applications. The designation of SME Status serves as a strategic initiative designed to foster innovation and encourage the creation of novel therapies. Instituted through the SME Regulation of

Within the context of the Clinical Trial Regulation, there is an essential emphasis on transparency. It is imperative that sponsors recognize their obligations concerning data transparency for trials executed in the EU, specifically those concluding under the Clinical Trial Directive (CTD). Sponsors are obligated to ensure that results from such studies are submitted to the