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The single submission process for approval to conduct research in all EU member states is facilitated by the Clinical Trials Information System (CTIS). [3] CTIS is an online portal which enables interactions between clinical trial sponsors (that is, the organization responsible for the conduct of the clinical trial), and the regulatory ...
Budget; Customs Union. Free Trade Agreements; European Single Market. Area of FS&J; Policies Agricultural; Energy; Fisheries; Regional; Citizenship. Passports of the ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.
The Finnish Medicines Agency (Fimea; Swedish: Säkerhets- och utvecklingscentret för läkemedelsområdet) [2] is a central agency under the Ministry of Social Affairs and Health that regulates medicines, medical devices, blood and tissue products, biobanks, and develops the pharmaceutical industry.
The Citation template generates a citation for a book, periodical, contribution in a collective work, or a web page. It determines the citation type by examining which parameters are used. Template parameters [Edit template data] This template has custom formatting. Parameter Description Type Status Last name last last1 author author1 author1-last author-last surname1 author-last1 subject1 ...