Traduction de «production procedures » (Anglais → Français) :

film production method | film production procedure | film production activity | film production process

bakery production processes | bakery production techniques | bakery production methods | bakery production procedures

biochemical procedures of cider production | biochemical process of cider production | biochemical processes of cider production | the biochemical processes of cider production

manufacturing process | operation sheet | production procedures

Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure [ TPLO ]

drafting of EU law [ Community legislative process | drafting of Community law | drafting of European Union law | EU legislative procedure | European Union legislative procedure ]

Certification procedures for products and parts

mobilisation procedures and the supply of products

law of criminal procedure | criminal procedure law | criminal procedural law | criminal procedure

procedural witness protection measure | procedural protective measure for witnesses | protective measure for witnesses at trial | procedural protection measure | procedural measure

EUROPA - EU law and publications - EUR-Lex - EUR-Lex - 32010R1235R(01) - EN - Corrigendum to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products ( OJ L 3 ...[+++]48, 31.12.2010 ) // Corrigendum to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products - Official Journal of the European Union L 348 of 31 December 2010

These provisions require that an operator or importer who learns that their product might constitute a risk to the public's health notify an inspector; they must prepare a recall procedure and operators must prepare written procedures and keep records for receiving, investigating and responding to product complaints.

Question No. 53 Ms. Kirsty Duncan: With respect to the chronic cerebrospinal venous insufficiency (CCSVI) clinical trial being undertaken by Dr. Traboulse: (a) what milestones are reportable to the government, (i) on what date(s) is reporting expected to occur, (ii) how will this information be communicated to patients, the medical community, and the general public; (b) on what date did each of the trial sites pass ethical review; (c) on what date did recruitment of patients begin for each of the trial sites; (d) how many patients with multiple sclerosis (MS) are being recruited for each site, and how is consistency in diagnosis and treatment being ensured across sites; (e) who is performing the diagnoses for CCSVI for each site, (i) ho ...[+++]w is the diagnosis being performed, including, but not limited to, ultrasound and venogram, (ii) how many diagnoses has each person undertaking the diagnosis at each site performed prior to the study, and by whom was each person trained; (f) who is performing the procedures for each site, (i) how is the procedure being performed, including, but not limited to, anesthetic, balloon size, (ii) how many procedures has each person undertaking the procedure at each site performed prior to the study, and by whom was each person trained; (g) what are the selection criteria for the trial, including, but not limited to, type of MS, Expanded Disability Status Scale (EDSS) score, venous abnormality/malformed valve/stenosis, mobility, (i) how do these criteria compare with the international literature, (ii) with how many international studies to date will the selection criteria be analytically comparable; (h) if both progressive and relapsing-remitting forms of MS are to be examined in the trial, how will statistical significance be ensured given that 50 of 100 patients will undergo a “sham” procedure, 25 patients will have a progressive form of the disease, and 25 will have a relapsing-remitting form of the disease, and will people with bo ...

(b)‘Technical specification’, in the case of supply or service contracts: a specification in a document defining the required characteristics of a product or service, such as quality and environmental performance levels, design for all requirements (including accessibility for people with disabilities), and conformity-assessment, performance, use of the product, its safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production methods and procedures, as well as conformity a ...[+++]ssessment procedures.