Traduction de «Essai avec groupes parallèles » (Français → Anglais) :

the relevance of the clinical trial, including whether the groups of subjects participating in the clinical trial represent the population to be treated, or if not, the explanation and justification provided in accordance with point (y) of paragraph 17 of Annex I to this Regulation; the current state of scientific knowledge; whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products; and, where applicable, any opinion formulated by the Paediatric Committee on a paediatric investigation plan in accordance with Regu ...[+++]lation (EC) No 1901/2006 of the European Parliament and of the Council

(Return tabled) Question No. 1123 Ms. Kirsty Duncan: With respect to the government’s position on chronic cerebrospinal venous insufficiency (CCSVI): (a) does the government track clinical trials on CCSVI currently being undertaken by other countries and, if yes, what are all clinical trials, identified by phase, currently being undertaken worldwide, (i) which countries are undertaking Phase lll trials; (b) does the government question whether CCSVI exists and, if yes, (i) why does the government not question whether treating CCSVI actually improves quality of life for Canadians with multiple sclerosis (MS); (c) how many cases of " major complications associated with venous angioplasty" have ...[+++] occurred in Canada and, if it is not possible to give this number, why, (i) what are identified complications to CCSVI and, for each complication, how many cases versus the number of procedures undertaken have occurred; (d) what are all procedures that have been performed on veins in Canada, including, procedures for Budd-Chiari syndrome and May-Thurner syndrome; (e) what is the government's position on ballooning veins and why does it consider that ballooning veins even once could be unsafe on fragile veins, even though participants involved in the proposed clinical trial will experience two procedures-one real, one simulated-in a one-year period; (f) is the government consulting with Canadians with MS, if so, (i) provide a list of all CCSVI groups the Minister of Health has met with along with the dates of the meetings, (ii) provide a list of all MS groups the Minister of Health has met with along with the dates of the meetings, (iii) provide the number of Canadians with MS the Minister of Health has met and the dates of all meetings, and if the government is not consulting, (iv) why not; (g) how does inviting the investigators of the seven MS-funded CCSVI studies to participate in the consensus workshop on ultrasound imaging meet CIHR's conflict of interest g ...

Treatment of garlic capsules (in exactly the same concentration as the raw product) as a medicine, attracting an onerous authorisation procedure. Complete absence (or inadequacy) of parallel import procedures for medicines or for pesticides, obliging products imported in parallel to undergo the same testing as the (identical or almost identical) authorised proprietary product has already gone through. Subjecting animal cages, road traffic equipment and other products to heavy type approval procedures based on outdated product specific ...[+++]ations rather than straightforward functional performance tests.

The marketing of a medicinal product having been authorised, it would be unnecessary, disproportionate, time consuming and costly to apply exactly the same procedure often involving extensive clinical tests - all over again to a product imported in parallel which is exactly the same or sufficiently similar to the one already authorised.

The creation of an international expert group parallel to the EU validation study, which was charged to draft a General Method for the new tests, might have slowed down acceptance of the new tests.

You have more parallel tracks—or there were more parallel tracks, but they're trying to get rid of them.