European Union Clinical Trials Regulation information

The European Union Clinical Trials Regulation (regulation (EU) No 536/2014) is the legislation relating to the conduct of clinical trials of investigational...

governing clinical trials in the European Community, by establishing a clear, transparent procedure. The Member States of the European Union had to adopt...

Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving...

European Union law is a system of rules operating within the member states of the European Union (EU). Since the founding of the European Coal and Steel...

The Air Passengers Rights Regulation 2004 (Regulation (EC) No 261/2004) is a regulation in EU law establishing common rules on compensation and assistance...

Human Use, a guideline for regulation of clinical trials ClinicalTrials.gov, a worldwide database of registered clinical trials; US National Library of Medicine...

studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU)...

clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical...

a clinical trial must publicly document it in the Clinical Trials Registry - India. Various government agencies and laws regulate clinical trials. The...

knowledge of good clinical practice and local regulations. The main function of a clinical research associate is to monitor clinical trials. The CRA may work...

Taiwan, European Union, and the United States (including Puerto Rico). All nine trials were used to assess safety and five of these trials were used...

European Council gave its final approval to the Regulation on a Digital Services Act. It was published in the Official Journal of the European Union on...

subjects in clinical trials 54 Financial disclosure by clinical investigators 56 Institutional review boards that oversee clinical trials 58 Good laboratory...

enacted in October 1995, was a European Union directive which regulated the processing of personal data within the European Union (EU) and the free movement...

The European and Developing Countries Clinical Trials Partnership (EDCTP) is a partnership between the European Union (EU), Norway, Switzerland and developing...

The Rule of Law Conditionality Regulation is a regulation of the European Union and Euratom, which allows the European Commission to adopt measures, including...

EudraLex is the collection of rules and regulations governing medicinal products in the European Union. EudraLex consists of 10 volumes: Concerning Medicinal...

Surveillance Study. With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to...

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior...

biotechnology Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic...

treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." In the 1980s the European Union began harmonising...

obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing...

Laboratory Practices (GLP) for clinical trial applications governed by the EU Clinical Trials Regulation (Regulation (EU) No 536/2014). This paper was...