Traduction de «report on safety » (Néerlandais → Français) :

Verzamelen en evalueren van periodieke verslagen op het gebied van geneesmiddelenbewaking (Periodic Safety Update Report - PSUR) en van veiligheidsverslagen betreffende klinische studies (Annual Safety Report - ASR) uitgevoerd met in België vergunde geneesmiddelen;
Le recueil et l’évaluation des rapports périodiques de pharmacovigilance (Periodic Safety Update Report - PSUR) et des rapports de sécurité relatifs à des essais cliniques (Annual Safety Report - ASR) réalisés avec des médicaments autorisés en Belgique ;

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

Contract Research Report 343/2001, prepared by the Institute fo sound and Vibration Research for the Health and Safety Executive. London Health and Safety. 2001. Internet: [http ...]
London Health and Safety Executive; 2001. contract Research Report 343/2001, prepared by the Institute fo sound and Vibration Research for the Health and Safety Executive.

haemovigilance data and monitoring their implementation ●● The first annual report of the Haemovigilance Centre was published in 2007 Since November 2005, hospitals and blood establishments have been required to report to the Belgian Centre for Haemovigilance of the FAMHP serious reactions during the collection or administration of blood components and serious events relating to the quality or safety of blood components.
haemovigilance data and monitoring their implementation ●● The first annual report of the Haemovigilance Centre was published in 2007 Since November 2005, hospitals and blood establishments have been required to report to the Belgian Centre for Haemovigilance of the FAMHP serious reactions during the collection or administration of blood components and serious events relating to the quality or safety of blood components.

Het is ook belangrijk om kwalitatieve evaluaties te maken van de vigilantie-informatie (bijvoorbeeld aan de hand van case reports, Periodic Safety Update Report - PSUR, jaarlijks veiligheidsverslag - ASR), die het mogelijk maken om juiste, coherente en wetenschappelijk gegronde beslissingen te nemen.
Il est également important de réaliser des évaluations de qualité des informations de vigilance (par exemple des case reports, des Periodic Safety Update Report - PSUR, des rapports annuels de sécurité - ASR) qui permettent la prise de décisions appropriées, cohérentes et scientifiquement fondées.

The issue of the rather high supplementary intake of group B vitamins - which raises questions at a nutritional level (AFSSA, 2006 and previous advisory reports of the Belgian Superior Health Council: see below) - is not discussed in this advisory report because, in spite of their unnecessarily high addition, they do not appear to cause any concern with respect to food safety.
La problématique des apports complémentaires assez élevés en vitamines du groupe B qui pose question au plan nutritionnel (AFSSA, 2006 et précédents avis du conseil Supérieur de la Santé de Belgique: voir ci-après) n’est pas considérée dans le présent avis, notamment parce qu’elle ne semble pas soulever d’objections au plan de la sécurité alimentaire même si ces apports sont inutilement trop élevés.

Eind 2010 kwam een nieuwe collega de Afdeling R&D (humaan) versterken voor de beoordeling van het luik Safety Reporting bij klinische proeven.
Un nouveau collaborateur est venu renforcer la Division R&D (humain) à la fin de l’année 2010 dans le but d’évaluer le volet Safety Reporting des essais cliniques.

1. Renewal of a national marketing authorisation. 2 Periodic safety reports for medicines approved according to national, MRP, DCP and centralised procedures.
1. Renewal of a national marketing authorisation. 2 Periodic safety reports for medicines approved according to national, MRP, DCP and centralised procedures.

In a report of 15 January 2009, the European Food Safety Authority (EFSA) gives its opinion about the innocuousness of taurine and D-glucuronolactone as individual ingredients of energy drinks. This is based on new data from the literature and recent studies by the same applicant (EFSA, 2009).
Enfin, dans un rapport du 15 janvier 2009, l’European Food Safety Authority (EFSA) se prononce sur l’innocuité de la taurine et de la D-glucuronolactone en tant qu’ingrédients individuels de boissons énergisantes en se fondant sur les données récentes de la littérature et de nouvelles études fournies par le même pétitionnaire mais ne procède pas à une évaluation de l’innocuité de ces boissons en tant que telles (EFSA, 2009).

HGR 8838: Peptide Receptor Radionuclide Therapy “In this advisory report, the Superior Health Council provides a risk assessment (efficacy, toxicity, safety and radioprotection) for Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium-177 and Yttrium-90 for patients diagnosed with gastroenteropancreatic neuroendocrine tumours.
CSS 8838: Peptide Receptor Radionuclide Therapy “In this advisory report, the Superior Health Council provides a risk assessment (efficacy, toxicity, safety and radioprotection) for Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium-177 and Yttrium-90 for patients diagnosed with gastroenteropancreatic neuroendocrine tumours.