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To take into account the cross-border and global dimension of medicines markets, OMCLs co-operate actively at the European level and beyond. They do so through the General European OMCL Network (GEON), which was set up jointly by the Council of Europe and the European Commission (EC) in 1995. A number of non-European OMCLs have joined 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]).
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
EFQM (the European Foundation for Quality Management) is a non-profit membership foundation established in 1989 in Brussels, when CEOs of 67 European companies subscribed to the policy document and declared their commitments to EFQMs missions and values. [1]
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
The main application is the construction, erection and operation of industrial plants where the number of documents of all engineering disciplines may sum up to some 100,000 documents. During 2024, the new cross-standard ISO / IEC 81355 [ 2 ] will be published and will replace the second edition of IEC 61355-1 published in 2008.
The EFQM Excellence Award now known as The EFQM Global Award is a quality award that recognises European businesses with "excellent and sustainable results" across all areas of The EFQM Model. [1] [2] It was established in October 1991 as the European Quality Award by the European Foundation for Quality Management . The assessment process is ...