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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 ...
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.
Those diagnosed with COVID-19 or who believe they may be infected are advised by healthcare authorities to stay home except to get medical care, call ahead before visiting a healthcare provider, wear a face mask before entering the healthcare provider's office and when in any room or vehicle with another person, cover coughs and sneezes with a ...