Traduction de «all relevant applications for clinical trials » (Néerlandais → Français) :

The R&D (research and development) department is required to deal with all relevant applications for clinical trials.
The R&D (research and development) department is required to deal with all relevant applications for clinical trials.

The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.
The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.

In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.
In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.

The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.
The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.

Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.
Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.

The law of 7 May 2004 relating to experiments on the human person in Belgium provides that any objections from the FAMHP need to be submitted within a maximum of 28 days following the validation of applications for clinical trials.
The law of 7 May 2004 relating to experiments on the human person in Belgium provides that any objections from the FAMHP need to be submitted within a maximum of 28 days following the validation of applications for clinical trials.

Table 2: Search for additional RCTs Search Benefit and harms of mammography screening (40-49 y) questions Note Specific search for RCT’s Date 27/04/2010 Keywords Breast neoplasms (MESH), mass screening (or early detection) (MESH), mammography (MESH) Medline 1 Randomized controlled trials/ (66083) Medline (OVID): (OVID): 2 Randomized controlled trial.pt (289038) Filter Filter 3 Random allocation/ (67885) RCT RCT 4 Double blind method/ (105956) 5 Single blind method/ (13834) 6 Clinical trial.pt (460563) 7 exp clinical trial/ (606505) 8 or/1-7 (718664) 9 (clinic$ adj trial$).tw (146686) 10 ((singl$ or doubl$ or treb$ or tripl$) adj (blind$3 or mask$3)).tw (105209) 11 Placebos/ (28712) 12 Placebo$.tw (125428) 13 Randomly allocated.tw (12231) 14 (allocated adj2 random).tw (654) 15 9 or 10 or 11 or 12 or 13 or 14 (312732) 16 8 or 15 (842155) 17 Case report.tw (155883) 18 Letter.pt (688664) 19 Historical article.pt (263287) 20 Review of reported cases.pt (0) 21 Review,multicase.pt (0) 22 17 or 18 or 19 or 20 or 21 (1098644) 23 16 not 22 (822810) 24 Breast/ or Breast Diseases/ (30717) 25 Neoplasms/ (216644) 26 24 and 25 (535) 27 (breast$ adj5 neoplasm$).tw (1588) 28 (breast$ adj5 cancer$).tw (135654) 29 (breast$ adj5 carcin$).tw (31778) 30 (breast$ adj5 tumo$).tw (23438) 31 (breast$ adj5 metasta$).tw (16580) 32 (breast$ adj5 malig$).tw (7361) 33 exp Breast Neoplasms/ (171606) 34 exp Carcinoma, Ductal, Breast/ (8460) 35 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 (207174) 36 mammography.mp (23598) 37 screening.mp (274211) 38 36 or 37 (288429) 39 23 and 35 and 38 (2326) 40 limit 39 to (yr=" 2008 -Current" and " all adult (19 plus years)" and (dutch or english or french)) (241) 41 from 40 keep 1-241 (241) 42 from 41 keep 1-241 (241) CENTRAL Breast neoplasms (MESH) and early detection (MESH) or 61 mammography (MESH) (manual limit 2008-2010) in title , abstracts or key words
Table 4: Search for additional RCTs Search Benefit and harms of mammography screening (40-49 y) questions Note Specific search for RCT’s Date 27/04/2010 Keywords Breast neoplasms (MESH), mass screening (or early detection) (MESH), mammography (MESH) Medline 1 Randomized controlled trials/ (66083) Medline (OVID): (OVID): 2 Randomized controlled trial.pt (289038) Filter Filter 3 Random allocation/ (67885) RCT RCT 4 Double blind method/ (105956) 5 Single blind method/ (13834) 6 Clinical trial.pt (460563) 7 exp clinical trial/ (606505) 8 or/1-7 (718664) 9 (clinic$ adj trial$).tw (146686) 10 ((singl$ or doubl$ or treb$ or tripl$) adj (blind$3 or mask$3)).tw (105209) 11 Placebos/ (28712) 12 Placebo$.tw (125428) 13 Randomly allocated.tw (12231) 14 (allocated adj2 random).tw (654) 15 9 or 10 or 11 or 12 or 13 or 14 (312732) 16 8 or 15 (842155) 17 Case report.tw (155883) 18 Letter.pt (688664) 19 Historical article.pt (263287) 20 Review of reported cases.pt (0) 21 Review,multicase.pt (0) 22 17 or 18 or 19 or 20 or 21 (1098644) 23 16 not 22 (822810) 24 Breast/ or Breast Diseases/ (30717) 25 Neoplasms/ (216644) 26 24 and 25 (535) 27 (breast$ adj5 neoplasm$).tw (1588) 28 (breast$ adj5 cancer$).tw (135654) 29 (breast$ adj5 carcin$).tw (31778) 30 (breast$ adj5 tumo$).tw (23438) 31 (breast$ adj5 metasta$).tw (16580) 32 (breast$ adj5 malig$).tw (7361) 33 exp Breast Neoplasms/ (171606) 34 exp Carcinoma, Ductal, Breast/ (8460) 35 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 (207174) 36 mammography.mp (23598) 37 screening.mp (274211) 38 36 or 37 (288429) 39 23 and 35 and 38 (2326) 40 limit 39 to (yr=" 2008 -Current" and " all adult (19 plus years)" and (dutch or english or french)) (241) 41 from 40 keep 1-241 (241) 42 from 41 keep 1-241 (241) CENTRAL Breast neoplasms (MESH) and early detection (MESH) or 61 mammography (MESH) (manual limit 2008-2010) in title , abstracts or key words

The FAMHP wants: ●● To emerge as a point of reference for scientific advice ●● To attract clinical trials ●● To act as rapporteur or RMS in the evaluation of registration applications for important products ●● Where relevant, to be a point of reference
The FAMHP wants: ●● To emerge as a point of reference for scientific advice ●● To attract clinical trials ●● To act as rapporteur or RMS in the evaluation of registration applications for important products ●● Where relevant, to be a point of reference

No new clinical trials are required, and Novartis expects to respond to all questions fully in 2009.
Ce qui ne nécessite pas de nouveaux essais cliniques et Novartis espère pouvoir fournir des réponses complètes à toutes les questions en 2009.