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The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...
Strict rules of evidence is a term sometimes used in and about Anglophone common law.The term is not always seen as belonging to technical legal terminology; legislation seldom if ever names a set of laws with the term "strict rules of evidence"; and the term's precise application varies from one legal context to another.
The European Union Clinical Trials Regulation (regulation (EU) No 536/2014) is the legislation relating to the conduct of clinical trials of investigational medicinal products within the European Union. The regulations repealed the previous legislation, namely the clinical trials directive and came into force on 31 January 2022. [1]
In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3] A ...
A subsequent remedial measure is an improvement, repair, or safety measure made after an injury has occurred. FRE 407 [dead link ] prohibits the admission of evidence of subsequent remedial measures to show defendant's (1) negligence; (2) culpable conduct; (3) a defect in defendant's product; (4) defect in the design of defendant's product; or (5) the need for a warning or instruction.
Under the Federal Rules of Evidence 803 (18), either party can introduce a learned treatise as evidence, irrespective of whether it is being used to rebut the opposing party. Such texts are now considered an exception to hearsay, with two limitations: [3] For the learned treatise to be introduced, there must be an expert witness on the stand;
Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts; Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products; Directive 2001/20/EC, defines rules for the conduct of clinical trials; Directive 2001/83/EC