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Vertaling van "production quality and pharmacovigilance " (Nederlands → Frans) :

This article stipulates The regulation states that production, quality and pharmacovigilance standards need to be determined for these products;

This article stipulates The regulation states that production, quality and pharmacovigilance standards need to be determined for these products;


The seriousness of the situation, the differences in regulations from country to country, the difficulty of determining at the start of an incident whether it is a quality problem or a problem of pharmacovigilance, are factors which have to be taken into account.

The seriousness of the situation, the differences in regulations from country to country, the difficulty of determining at the start of an incident whether it is a quality problem or a problem of pharmacovigilance, are factors which have to be taken into account.


Close cooperation with the representatives on the CHMP working groups (e.g. pharmacovigilance, scientific advice, quality, safety, biological) is necessary.

Close cooperation with the representatives on the CHMP working groups (e.g. pharmacovigilance, scientific advice, quality, safety, biological) is necessary.


De rol en de verantwoordelijkheden van de verantwoordelijke persoon inzake geneesmiddelenbewaking zijn uitvoerig beschreven in Eudralex “Volume 9B Guidelines on Pharmacovigilance of Veterinary Medicinal Products "

Le rôle et les responsabilités de la personne responsable en matière de pharmacovigilance sont détaillées dans l’Eudralex " Volume 9B Guidelines on Pharmacovigilance of Veterinary Medicinal Products " .


De werkgroep is per definitie een meer uitgebreide transversale, interdisciplinaire groep en is samengesteld uit de leden van het projectteam plus leden van Committee for Medicinal Products for Human Use (CHMP), Committee for Advanced Therapies (CAT), Paediatric Committee (PDCO) (inclusief voorzitter), PharmacoVigilance Working Party (PhVWP), Scientific Advice Working Party (SAWP) en Co-ordination Group for Mutual Recognition and Decentralised Procedure, human (CMDh).

Le groupe de travail est par définition un groupe interdisciplinaire et transversal plus large, et se compose des membres de l’équipe de projet plus des membres du Committee for Medicinal Products for Human Use (CHMP), Committee for Advanced Therapies (CAT), Paediatric Committee (PDCO) (y compris le président), PharmacoVigilance Working Party (PhVWP), Scientific Advice Working Party (SAWP) et du Co-ordination Group for Mutual Recognition and Decentralised Procedure, human (CMDh).


Er kan steeds advies gevraagd worden aan het Departement Goed Gebruik van het Geneesmiddel (BUM) van het FAGG en aan de leden van Efficacy Working Party (EWP), Safety Working Party (SWP), Biosimilar Medicinal Products Working Party (BMWP), Blood Working Party (BWP) en Quality Working Party (QWP).

On peut toujours demander un avis au Département Bon Usage du Médicament (BUM) de l’AFMPS et aux membres des groupes suivants : Efficacy Working Party (EWP), Safety Working Party (SWP), Biosimilar Medicinal Products Working Party (BMWP), Blood Working Party (BWP) et Quality Working Party (QWP).


In Europe, where pricing pressures have been most intense, overall growth was 8 %, with volume gains of 12 percentage points demonstrating the quality of the new product portfolio.

En Europe, où la pression sur les prix a été la plus forte, la croissance globale s’est inscrite à 8%, avec des gains en volume de 12 points ce qui démontre la qualité des nouveaux produits.


CARPENTIER Yvon * Voeding, pathologische biochemie ULB DE BACKER Guy * Preventieve geneeskunde, volksgezondheid, UGent epidemiologie DE HENAUW Stefaan * Public health nutrition UGent DELZENNE Nathalie * Voeding, toxicologie UCL DEMEYER Daniel Animal product quality, health value of animal UGent foods FONDU Michel chemie, additieven, contaminanten ULB HUYGHEBAERT André chemie, technologie UGent MAGHUIN-ROGISTER Guy * levensmiddelenanalyse ULg NEVE Jean * therapeutische chemie en ULB voedingswetenschappen PAQUOT Michel * chemie, technologie Gembloux Agro-Bio Tech

CARPENTIER Yvon * Nutrition, biochimie pathologique ULB DE BACKER Guy * Médecine préventive, santé publique, UGent épidémiologie DE HENAUW Stefaan * Public health nutrition UGent DELZENNE Nathalie * Nutrition, toxicologie UCL DEMEYER Daniel Animal product quality, health value of animal UGent foods FONDU Michel Chimie, additifs, contaminants ULB HUYGHEBAERT André Chimie, technologie UGent MAGHUIN-ROGISTER Guy * Analyse des denrées alimentaires ULg NEVE Jean * Chimie thérapeutique et sciences ULB nutritionnelles PAQUOT Michel * Chimie, technologie Gembloux Agro-Bio Tech


het Zoötechnisch Centrum (R&D / Laboratory Quality Care in Animal Production) van KULeuven (www.biw.kuleuven.be)

le Centre zootechnique (K.U.Leuven R&D / Laboratory Quality Care in Animal Production) de l'Université catholique de Louvain (www.biw.kuleuven.be)


The Scientific Committee’s mission consists of coordinating and harmonising activities carried out by the various FAMHP commissions with a view to guaranteeing the quality, safety and efficacy of medicines and health products.

The Scientific Committee’s mission consists of coordinating and harmonising activities carried out by the various FAMHP commissions with a view to guaranteeing the quality, safety and efficacy of medicines and health products.




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Date index: 2022-11-16
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