Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.
Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
Latest Glossary Definitions
The process of rendering data into a form which does not identify individuals and where identification is not likely to take place, for example to comply with the requirements of Policy 70.
Named after the silica, main component of computer parts. In silico technologies encompass a large number of approaches that may assist in the prediction of toxicity and fate of new and existing chemicals.
When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose to go through the Voluntary Harmonization Procedure (VHP) as an alternative to the classical separate Clinical Trial Application to each Competent Authority.
The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference o
Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by
Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally designated representative(s), shall be fully informed about the clinical trial in order to make an informed decision regarding their participation.
The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.