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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 ...
On 26 May 1994, the European Commission and the Council of Europe decided to launch a new, jointly funded, co-operative venture targeting the quality control of medicines for human and veterinary use on the market, called the European Network of Official Medicines Control Laboratories (OMCLs). [9]
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]
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
Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)
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 ...
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.