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Adverse Effects

Traduction de «reporting adverse effects » (Néerlandais → Français) :

Table 3: Update of evidence found in SR and HTA Search Radiation harms of mammography screening (40-49 y) questions Note Update of HTA (ETMIS) Date 03/05/2010 Keywords Breast neoplasms, mammography/ adverse effects, mass screening/ adverse effects Medline Case report.tw (156081) (OVID): 2 Letter.pt (689184) Filter 3 Historical article.pt (263481) RCT 4 Review of reported cases.pt (0) 5 Review,multicase.pt (0) 6 or/1-5 (1099551) 7 Breast/ or Breast Diseases/ (30731) 8 Neoplasms/ (216844) 9 7 an ...[+++]

Table 5: Update of evidence found in SR and HTA Search Radiation harms of mammography screening (40-49 y) questions Note Update of HTA (ETMIS) Date 03/05/2010 Keywords Breast neoplasms, mammography/ adverse effects, mass screening/ adverse effects Medline Case report.tw (156081) (OVID): 2 Letter.pt (689184) Filter 3 Historical article.pt (263481) RCT 4 Review of reported cases.pt (0) 5 Review,multicase.pt (0) 6 or/1-5 (1099551) 7 Breast/ or Breast Diseases/ (30731) 8 Neoplasms/ (216844) 9 7 an ...[+++]


Healthcare professionals and consumers of medicines and health products need to be made aware of the utility and obligation (in the case of materiovigilance and haemovigilance) of reporting adverse effects and adverse events associated with the use of medicines and health products to the FAMHP. Furthermore, the report form should be made easy to complete

Healthcare professionals and consumers of medicines and health products need to be made aware of the utility and obligation (in the case of materiovigilance and haemovigilance) of reporting adverse effects and adverse events associated with the use of medicines and health products to the FAMHP. Furthermore, the report form should be made easy to complete


The evaluation of oncological adverse effects (as well as the evaluation of the Periodic Safety Update Report – PSUR, Annual Safety Report - ASR, Suspected Unexpected Serious Adverse Reaction

The evaluation of oncological adverse effects (as well as the evaluation of the Periodic Safety Update Report – PSUR, Annual Safety Report - ASR, Suspected Unexpected Serious Adverse Reaction


Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.

Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.


Both the SCF’s 2003 opinion and the advisory report recently published by the German Federal Institute for Risk Assessment (BfR, 2008) mention a number of observation cases and reported cases with acute adverse effects, including death, in people who consume energy drinks.

L’avis du SCF de 2003 ainsi que l’avis récemment émis par l’Institut fédéral allemand d’évaluation des risques (BfR, 2008) mentionnent un certain nombre de cas d’observation et de cas rapportés signalant des effets nocifs aigus, comprenant des décès, chez des sujets consommant des boissons énergisantes.


A final element that needs to be added to this file is the very recent report of the French toxicovigilance co-ordination committee (Comité de Coordination de Toxicovigilance Français – CCTF) (CCTF, 2009). It describes the results of the prospective follow-up of the adverse effects of consuming energy drinks, especially during the five months that passed after the most famous of these drinks was allowed to be marketed in France (15 July 2008).

Un dernier élément à verser au dossier est le très récent rapport du comité de coordination de toxicovigilance français (CCTF) qui relate les résultats du suivi prospectif des effets indésirables liés à la consommation de boissons énergisantes, en particulier dans les 5 mois qui ont suivi l’autorisation de commercialisation de la plus connue d’entreelles en France (15 juillet 2008) (CCTF, 2009).


At the end of 2007 the FAMHP initiated a programme for specific monitoring of new medicines (“black triangle” – symbol included in the BCFI-CBIP annotated drugs formulary – Gecommentarieerd Geneesmiddelenrepertorium – Répertoire Commenté des Médicaments) with the aim of encouraging healthcare professionals to report adverse effects of medicines with a new active substance to the FAMHP.

At the end of 2007 the FAMHP initiated a programme for specific monitoring of new medicines (“black triangle” – symbol included in the BCFI-CBIP annotated drugs formulary – Gecommentarieerd Geneesmiddelenrepertorium – Répertoire Commenté des Médicaments) with the aim of encouraging healthcare professionals to report adverse effects of medicines with a new active substance to the FAMHP.




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Date index: 2024-08-28
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