{"id":322510,"date":"2021-05-12T04:02:19","date_gmt":"2021-05-12T08:02:19","guid":{"rendered":"https:\/\/gijn.org\/?page_id=322510"},"modified":"2023-09-05T08:34:54","modified_gmt":"2023-09-05T12:34:54","slug":"enqueter-sur-la-sante-et-la-medecine-glossaire-agences-et-livres","status":"publish","type":"post","link":"https:\/\/gijn.org\/fr\/ressource\/enqueter-sur-la-sante-et-la-medecine-glossaire-agences-et-livres\/","title":{"rendered":"Enqu\u00eater sur la sant\u00e9 et la m\u00e9decine: Glossaire, agences, et livres"},"content":{"rendered":"<h2>Annexe A : glossaire des termes<\/h2>\n<h4><strong>D\u00e9claration d\u2019effets ind\u00e9sirables\u00a0<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Signalements fournis par les patients et les professionnels de sant\u00e9 aux organismes de r\u00e9glementation nationaux et internationaux concernant les effets ind\u00e9sirables de m\u00e9dicaments et de dispositifs m\u00e9dicaux. Voir, par exemple, <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.fda.gov\/drugs\/surveillance\/questions-and-answers-fdas-adverse-event-reporting-system-faers\"><span style=\"font-weight: 400;\">le syst\u00e8me de la FDA <\/span><\/a><span style=\"font-weight: 400;\">aux Etats-Unis<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h4><strong>Biomarqueurs<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Les marqueurs biologiques font r\u00e9f\u00e9rence \u00e0 une large sous-cat\u00e9gorie de signes m\u00e9dicaux (ou signes cliniques), c&rsquo;est-\u00e0-dire des manifestations objectives de l&rsquo;\u00e9tat m\u00e9dical d&rsquo;un patient, observ\u00e9es non par le patient, mais par quelqu\u2019un de l&rsquo;ext\u00e9rieur. Ceux-ci peuvent \u00eatre mesur\u00e9s avec pr\u00e9cision et leurs r\u00e9sultats peuvent \u00eatre reproduits. C&rsquo;est le cas par exemple d&rsquo;un r\u00e9sultat de test sanguin. Les signes m\u00e9dicaux contrastent avec les sympt\u00f4mes m\u00e9dicaux, qui se limitent aux signes de sant\u00e9 ou de maladie per\u00e7us par les patients eux-m\u00eames.<\/span><\/p>\n<h4><strong>Aveugle<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Situation o\u00f9 les participants \u00e0 une \u00e9tude ignorent s&rsquo;ils re\u00e7oivent ou non une intervention. Dans le cas d\u2019une \u00e9tude en double aveugle, le personnel m\u00e9dical qui administre le traitement l\u2019ignore aussi. De nombreuses \u00e9tudes ont montr\u00e9 que si vous savez quel traitement vous recevez, il se peut que l\u2019effet placebo soit plus important chez vous que chez un sujet qui ne sait pas quel traitement on lui administre.<\/span><\/p>\n<h4><strong>Facteurs confondants et biais<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Un facteur confondant est une variable qui peut influencer les r\u00e9sultats d&rsquo;une \u00e9tude ou d&rsquo;une analyse. Par exemple, lorsqu\u2019on compare la situation \u00e9pid\u00e9miologique de deux pays, sans tenir compte de l&rsquo;\u00e2ge de la population. Or, certains pays ont une population beaucoup plus \u00e2g\u00e9e que d&rsquo;autres, et cela peut influencer l\u2019analyse de mani\u00e8re importante. Dans cet exemple, l&rsquo;\u00e2ge de la population est le facteur confondant. Lors de l&rsquo;analyse d&rsquo;un ensemble de donn\u00e9es ou du r\u00e9sultat d&rsquo;une \u00e9tude, les chercheurs essaient de proc\u00e9der \u00e0 des ajustements pour exclure tout facteur confondant, et obtenir ainsi une r\u00e9ponse plus fiable \u00e0 la question de recherche. Le biais est d\u00e9fini comme une erreur syst\u00e9matique (ou \u00ab\u00a0erreur non al\u00e9atoire\u00a0\u00bb) qui interf\u00e8re dans l\u2019\u00e9valuation pr\u00e9cise des r\u00e9sultats d&rsquo;une \u00e9tude. Lecture compl\u00e9mentaire :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2917255\/\"><span style=\"font-weight: 400;\">Identifying and Avoiding Bias in Research<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><span style=\"font-weight: 400;\"> (Identifier et \u00e9viter les biais dans la recherche<\/span><span style=\"font-weight: 400;\">)<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h4><strong>Corr\u00e9lation et causalit\u00e9<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Il y a corr\u00e9lation lorsque deux ph\u00e9nom\u00e8nes sont li\u00e9s par une relation. Par exemple, il pleut et en m\u00eame temps, les lumi\u00e8res s\u2019\u00e9teignent dans votre logement. Ces deux \u00e9v\u00e9nements se produisent en m\u00eame temps, il y a donc une sorte de relation, mais on ne peut pas dire si les lumi\u00e8res se sont \u00e9teintes \u00e0 cause de la pluie. La causalit\u00e9, \u00e0 l\u2019inverse, indique que deux ph\u00e9nom\u00e8nes sont li\u00e9s par une relation de cause \u00e0 effet. Dans l&rsquo;exemple, vous appelez un sp\u00e9cialiste pour r\u00e9soudre votre probl\u00e8me d&rsquo;\u00e9lectricit\u00e9 et il vous explique que clairement, la pluie a bel et bien \u00e9teint les lumi\u00e8res en raison d\u2019une fuite dans votre immeuble. En m\u00e9thodologie scientifique, la diff\u00e9rence entre corr\u00e9lation et causalit\u00e9 est essentielle. De nombreux ph\u00e9nom\u00e8nes peuvent sembler li\u00e9s par une relation de cause \u00e0 effet, mais \u00e0 moins que celle-ci n\u2019ait \u00e9t\u00e9 prouv\u00e9e, nous devons plut\u00f4t partir du principe qu\u2019il s\u2019agit d\u2019une corr\u00e9lation. Consid\u00e9rer sans preuve un ph\u00e9nom\u00e8ne comme causal est un biais tr\u00e8s courant et probl\u00e9matique.<\/span><\/p>\n<h4><strong>Lecture critique<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Voici une d\u00e9finition dans un langage relativement simple : \u00ab\u00a0La lecture critique est le processus qui consiste \u00e0 \u00e9valuer soigneusement et syst\u00e9matiquement les r\u00e9sultats de la recherche scientifique (preuves) pour juger de leur fiabilit\u00e9, de leur valeur et de leur pertinence dans un contexte particulier.\u00a0\u00bb <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/cebma.org\/resources-and-tools\/what-is-critical-appraisal\/\">Source : What is Critical Appraisal ?<\/a> (<\/span><span style=\"font-weight: 400;\">Qu&rsquo;est-ce que la lecture critique ?) &#8211; Center for Evidence Based Management<\/span><span style=\"font-weight: 400;\">..<\/span><\/p>\n<h4><strong>Fa\u00e7onnage de maladies<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Le fa\u00e7onnage de maladies peut \u00eatre d\u00e9fini comme une mani\u00e8re de \u00ab\u00a0vendre <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/collections.plos.org\/disease-mongering\"><span style=\"font-weight: 400;\">la maladie<\/span><\/a>\u00ab\u00a0<span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">dans le but de promouvoir la vente de m\u00e9dicaments. C&rsquo;est une strat\u00e9gie utilis\u00e9e par les soci\u00e9t\u00e9s pharmaceutiques pour \u00e9largir le march\u00e9 potentiel de leurs produits, soit en inventant de nouvelles maladies, soit en pr\u00e9sentant un ph\u00e9nom\u00e8ne normal comme une maladie. Des sympt\u00f4mes courants, bien que non pathologiques, peuvent servir d&rsquo;indication \u00e0 un nouveau m\u00e9dicament ou de nouvelle indication pour un produit d\u00e9j\u00e0 commercialis\u00e9.<\/span><\/p>\n<h4><strong>Crit\u00e8res d\u2019\u00e9valuation : primaire, secondaire, de substitution, combin\u00e9<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Un essai clinique vise \u00e0 r\u00e9pondre \u00e0 une question de recherche. Les \u00ab\u00a0crit\u00e8res de jugement\u00a0\u00bb sont des indicateurs qui ont \u00e9t\u00e9 \u00e9tablis pour mesurer le r\u00e9sultat de l\u2019essai. Le crit\u00e8re de jugement principal d\u2019un essai portant sur un nouveau m\u00e9dicament oncologique pourrait \u00eatre par exemple le prolongement de la vie du patient et le crit\u00e8re secondaire, la dur\u00e9e de l\u2019absence de sympt\u00f4mes. L\u2019utilisation de crit\u00e8re de substitution repr\u00e9sente intrins\u00e8quement un signal d\u2019alerte ; dans cet exemple, cela pourrait \u00eatre l\u2019utilisation de la taille de la tumeur comme crit\u00e8re de substitution. Les crit\u00e8res combin\u00e9s utilisent deux crit\u00e8res ou davantage comme s\u2019il s\u2019agissait d\u2019une seule mesure. M\u00e9fiez-vous-en car leur utilisation est susceptible de biaiser les r\u00e9sultats de l&rsquo;\u00e9tude.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h4><strong>Agence europ\u00e9enne des m\u00e9dicaments (AEM ou EMA)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">L&rsquo;EMA est une agence de l&rsquo;Union europ\u00e9enne charg\u00e9e de l&rsquo;\u00e9valuation et de la<a href=\"https:\/\/gijn.org\/wp-content\/uploads\/2020\/11\/9-microscope.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-284942 size-medium\" src=\"https:\/\/gijn.org\/wp-content\/uploads\/2020\/11\/9-microscope-336x376.png\" alt=\"\" width=\"336\" height=\"376\" srcset=\"https:\/\/gijn.org\/wp-content\/uploads\/2020\/11\/9-microscope-336x376.png 336w, https:\/\/gijn.org\/wp-content\/uploads\/2020\/11\/9-microscope.png 536w\" sizes=\"auto, (max-width: 336px) 100vw, 336px\" \/><\/a> surveillance des m\u00e9dicaments. Comme celles de la Food and Drug Administration aux \u00c9tats-Unis, les d\u00e9cisions de l&rsquo;EMA ont une grande influence sur le march\u00e9 pharmaceutique mondial.<\/span><\/p>\n<h4><strong>Soins de sant\u00e9 fond\u00e9s sur les preuves<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Le terme d\u00e9signe une approche utilis\u00e9e par les prestataires de sant\u00e9 pour d\u00e9cider de l&rsquo;intervention appropri\u00e9e pour traiter une affection, en basant le processus d\u00e9cisionnel sur les \u00ab\u00a0meilleures donn\u00e9es probantes disponibles\u00a0\u00bb. Pour en savoir plus : <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3074860\/\"><span style=\"font-weight: 400;\">Evidence Based Health Care<\/span><\/a><span style=\"font-weight: 400;\"> (Soins de sant\u00e9 fond\u00e9s sur les preuves) <\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h4><strong>\u00c9tude exp\u00e9rimentale (\u00e9galement appel\u00e9e interventionnelle)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">\u00c9tude o\u00f9 toutes les conditions sont pr\u00e9d\u00e9termin\u00e9es et contr\u00f4l\u00e9es par la personne qui conduit l&rsquo;exp\u00e9rience. Pour en savoir plus : <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/abs\/10.1002\/9781118445112.stat05160\"><span style=\"font-weight: 400;\">D\u00e9finition de l&rsquo;\u00e9tude exp\u00e9rimentale.<\/span><\/a><\/p>\n<h4><strong>Pr\u00e9sentation en valeurs absolues (risque absolu)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Contrairement au risque relatif, le risque absolu donne une indication de la probabilit\u00e9 dans le temps<\/span><span style=\"font-weight: 400;\"> qu&rsquo;un \u00e9v\u00e9nement<\/span><span style=\"font-weight: 400;\"> se produise. Consultez ce site web pour obtenir des d\u00e9finitions pr\u00e9cises mais simples et de nombreux exemples : <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statisticshowto.com\/calculate-relative-risk\/\"><span style=\"font-weight: 400;\">Risque relatif et risque absolu : d\u00e9finition et exemple<\/span><span style=\"font-weight: 400;\">s<\/span><\/a><span style=\"font-weight: 400;\"> (en anglais). <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5851391\/\"><span style=\"font-weight: 400;\">Comprendre et expliquer le risque (en fran\u00e7ais).<\/span><\/a><\/p>\n<h4><strong>Avis de s\u00e9curit\u00e9 (\u00ab\u00a0Field Safety Notice\u00a0\u00bb)\u00a0<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">L&rsquo;avis qu&rsquo;un fabricant communique aux utilisateurs dans lequel il admet l\u2019existence d&rsquo;un grave probl\u00e8me de s\u00e9curit\u00e9 li\u00e9 \u00e0 l&rsquo;utilisation de son produit.<\/span><\/p>\n<h4><strong>\u00a0U.S. Food and Drug Administration (FDA)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">La FDA est une agence de r\u00e9glementation am\u00e9ricaine charg\u00e9e de la supervision des m\u00e9dicaments pharmaceutiques, des vaccins et des dispositifs m\u00e9dicaux. Comme celles de l\u2019Agence europ\u00e9enne des m\u00e9dicaments, les d\u00e9cisions de la FDA en mati\u00e8re de m\u00e9dicaments ont une grande influence sur le march\u00e9 pharmaceutique mondial.<\/span><\/p>\n<h4><strong>Indication<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Une indication d\u00e9crit l&rsquo;utilisation homologu\u00e9e d&rsquo;un produit pharmaceutique (tel qu&rsquo;un m\u00e9dicament, un test ou un vaccin). Cela signifie que les autorit\u00e9s r\u00e9glementaires ont examin\u00e9 les preuves soumises par le fabricant pour le traitement (ou le test) d&rsquo;une condition ou d&rsquo;une maladie, et ont autoris\u00e9 l&rsquo;entreprise \u00e0 commercialiser le produit pour cet usage sp\u00e9cifique. L&rsquo;\u00e9largissement de l&rsquo;indication est une pratique couramment utilis\u00e9e pour \u00e9largir le march\u00e9 d\u2019un produit. Elle se fait souvent \u00e9tape par \u00e9tape. Chaque fois, l\u2019industrie doit soumettre de nouvelles donn\u00e9es aux r\u00e9gulateurs.<\/span><\/p>\n<h4><strong>Intervention<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">L&rsquo;OMS d\u00e9finit une <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.who.int\/classifications\/ichi\/en\/\"><span style=\"font-weight: 400;\">intervention de sant\u00e9<\/span><\/a> <span style=\"font-weight: 400;\">comme : \u00ab\u00a0Un acte accompli pour, avec ou au nom d&rsquo;une personne ou d&rsquo;une population dont le but est d&rsquo;\u00e9valuer, d&rsquo;am\u00e9liorer, de maintenir, de promouvoir ou de modifier la sant\u00e9, le fonctionnement ou les conditions de sant\u00e9.\u00a0\u00bb<\/span><\/p>\n<h4><strong>Dispositif m\u00e9dical<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Voici la d\u00e9finition compl\u00e8te d&rsquo;un \u00ab\u00a0dispositif m\u00e9dical\u00a0\u00bb par l&rsquo;OMS: \u00ab\u00a0Tout instrument, appareil, instrument, machine, engin, implant, agent r\u00e9actif \u00e0 usage in vitro, logiciel, mat\u00e9riel ou autre article similaire ou apparent\u00e9, destin\u00e9 par le fabricant \u00e0 \u00eatre utilis\u00e9, seul ou en association, chez l\u2019homme, dans les buts suivants : diagnostic, pr\u00e9vention, suivi, traitement ou att\u00e9nuation de la maladie; diagnostic, suivi, traitement, att\u00e9nuation ou compensation d&rsquo;un traumatisme; \u00e9tude, remplacement, modification ou appui anatomique ou d&rsquo;un processus physiologique; appui aux fonctions vitales ou maintien de la vie; r\u00e9gulation de la conception; d\u00e9sinfection de dispositifs m\u00e9dicaux; fourniture d&rsquo;informations au moyen d&rsquo;un examen in vitro d&rsquo;\u00e9chantillons humains; et dont l\u2019 action principale voulue dans ou sur le corps humain n\u2019est pas obtenue par des moyens pharmacologiques ou immunologiques, ni par le m\u00e9tabolisme, mais dont la fonction peut \u00eatre assist\u00e9e par de tels moyens.\u00a0\u00bb<\/span><\/p>\n<p><span style=\"font-weight: 400;\">En savoir plus :\u00a0<\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/311666\/9789242512359-fre.pdf\"><span style=\"font-weight: 400;\">Le mod\u00e8le de cadre r\u00e9glementaire mondial de l\u2019OMS relatif aux dispositifs m\u00e9dicaux incluant les dispositifs m\u00e9dicaux de diagnostic in vitro<\/span><\/a> <span style=\"font-weight: 400;\">.<\/span><\/p>\n<h4><strong>M\u00e9ta-analyse<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Une m\u00e9ta-analyse est une analyse statistique qui combine les r\u00e9sultats de plusieurs \u00e9tudes comparables.<\/span><\/p>\n<h4><strong>Essais contr\u00f4l\u00e9s randomis\u00e9s, en double aveugle, multicentriques<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Le terme multicentrique indique qu&rsquo;un essai est conduit sur plusieurs sites diff\u00e9rents (h\u00f4pitaux, par exemple). Pour les essais contr\u00f4l\u00e9s randomis\u00e9s (ECR) en double aveugle, voir ci-dessous non randomis\u00e9, sans aveugle.<\/span><\/p>\n<h4><strong>Non randomis\u00e9, sans aveugle<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">La randomisation est un concept cl\u00e9 dans les \u00e9tudes scientifiques qui visent \u00e0 comparer deux groupes de sujets qui re\u00e7oivent des interventions diff\u00e9rentes (comme un m\u00e9dicament test\u00e9 et un placebo ou un autre m\u00e9dicament \u00e0 des fins de comparaison). Attribuer au hasard les patients \u00e0 l&rsquo;un des deux groupes permet de minimiser les biais et les facteurs confondants de sorte que les deux groupes se ressemblent autant que possible au d\u00e9but de l&rsquo;\u00e9tude. Toutefois, pour des raisons uniquement dues au hasard, des d\u00e9s\u00e9quilibres fondamentaux peuvent exister entre les deux groupes (groupe d\u2019intervention plus \u00e2g\u00e9 que le groupe de contr\u00f4le, par exemple), ce qui peut fausser le r\u00e9sultat.<\/span><\/p>\n<h4><strong>\u00c9tude observationnelle<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">\u00c9tude consistant \u00e0 observer les ph\u00e9nom\u00e8nes au fur et \u00e0 mesure qu&rsquo;ils se produisent ou se d\u00e9roulent et \u00e0 essayer de tirer des conclusions sur leurs causes sous-jacentes. Bien que les \u00e9tudes observationnelles puissent fournir des indices pr\u00e9cieux, elles ne peuvent pas fournir de preuves solides et d\u00e9finitives, car elles sont particuli\u00e8rement sujettes aux biais et aux facteurs confondants. La meilleure solution consiste en principe \u00e0 utiliser des \u00e9tudes observationnelles pour g\u00e9n\u00e9rer des hypoth\u00e8ses, puis \u00e0 tester ces derni\u00e8res dans le cadre d\u2019essais randomis\u00e9s contr\u00f4l\u00e9s qui autorisent des conclusions plus fermes sur l\u2019effet de l\u2019intervention.<\/span><\/p>\n<h4><strong>Changement de crit\u00e8re de jugement (\u00ab\u00a0outcome switching\u00a0\u00bb)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Le changement de crit\u00e8re de jugement est une pratique controvers\u00e9e qui consiste \u00e0 modifier le crit\u00e8re de jugement de l&rsquo;\u00e9tude alors que celle-ci a d\u00e9j\u00e0 d\u00e9marr\u00e9. Les chercheurs sont cens\u00e9s identifier le crit\u00e8re de jugement et le r\u00e9sultat attendu de l&rsquo;intervention m\u00e9dicale test\u00e9e dans un protocole d&rsquo;\u00e9tude avant le d\u00e9marrage de l&rsquo;essai. Si ce crit\u00e8re de jugement est abandonn\u00e9 \u00e0 mi-chemin d&rsquo;une \u00e9tude et remplac\u00e9 par un autre, c&rsquo;est peut-\u00eatre parce que les chercheurs ont examin\u00e9 les donn\u00e9es et n&rsquo;ont pas obtenu le r\u00e9sultat positif qu&rsquo;ils esp\u00e9raient.<\/span><\/p>\n<h4><strong>Pr\u00e9sentation en pourcentage (risque relatif)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Les National Institutes of Health aux \u00c9tats-Unis d\u00e9finissent le risque relatif comme \u00ab\u00a0le rapport entre la probabilit\u00e9 qu&rsquo;un \u00e9v\u00e9nement se produise dans le groupe expos\u00e9 et la probabilit\u00e9 que l&rsquo;\u00e9v\u00e9nement se produise dans le groupe non expos\u00e9. Par exemple, le risque relatif de d\u00e9velopper un cancer du poumon (\u00e9v\u00e9nement) chez les fumeurs (groupe expos\u00e9) par rapport aux non-fumeurs (groupe non expos\u00e9) correspond \u00e0 la probabilit\u00e9 de d\u00e9velopper un cancer du poumon chez les fumeurs divis\u00e9e par la probabilit\u00e9 de d\u00e9velopper un cancer du poumon chez les non-fumeurs. Le risque relatif ne fournit aucune information sur le risque absolu que l&rsquo;\u00e9v\u00e9nement se produise, mais plut\u00f4t sur la probabilit\u00e9 plus \u00e9lev\u00e9e ou plus faible de l&rsquo;\u00e9v\u00e9nement dans le groupe expos\u00e9 par rapport au groupe non expos\u00e9\u00a0\u00bb. Source : <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK430824\/\"><span style=\"font-weight: 400;\">Relative risk<\/span><\/a><span style=\"font-weight: 400;\"> (Risque relatif<\/span><span style=\"font-weight: 400;\">)<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h4><strong>Pharmacovigilance<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">La pharmacovigilance est d\u00e9finie par l&rsquo;<\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/311240\/9789242508253-fre.pdf?ua=1\"><span style=\"font-weight: 400;\">OMS<\/span><\/a><span style=\"font-weight: 400;\"> comme \u00ab\u00a0la science et les activit\u00e9s li\u00e9es \u00e0 la d\u00e9tection, l&rsquo;\u00e9valuation, la compr\u00e9hension et la pr\u00e9vention des effets ind\u00e9sirables des m\u00e9dicaments ou d&rsquo;autres probl\u00e8mes \u00e9ventuels li\u00e9s aux m\u00e9dicaments\u00a0\u00bb.<\/span><\/p>\n<h4><strong>Crit\u00e8res PICO<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">PICO est un outil qui permet de d\u00e9composer une question de recherche. L&rsquo;acronyme signifie Patient\/Population ; Intervention ; Comparaison ; R\u00e9sultats (\u00ab\u00a0outcome\u00a0\u00bb). Son utilisation permet de mener une recherche bien structur\u00e9e dans la litt\u00e9rature biom\u00e9dicale et peut \u00eatre aussi extr\u00eamement utile pour les journalistes qui ont besoin d&rsquo;examiner en d\u00e9tail les interventions m\u00e9dicales. En savoir plus : <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/mcw.libguides.com\/EBM\/PICO\"><span style=\"font-weight: 400;\">PICO &#8211; Evidence Based Medicine.<\/span><\/a><\/p>\n<h4><strong>Surveillance post-commercialisation (ou post-marketing)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Surveillance de la s\u00e9curit\u00e9 d&rsquo;un m\u00e9dicament ou d&rsquo;un vaccin apr\u00e8s sa mise sur le march\u00e9.<\/span><\/p>\n<h4><strong>Crit\u00e8re de jugement pr\u00e9d\u00e9fini<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Voir changement de crit\u00e8re de jugement.<\/span><\/p>\n<h4><strong>Demande d&rsquo;homologation\u00a0<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Pour qu\u2019un m\u00e9dicament ou un vaccin puisse \u00eatre commercialis\u00e9, le fabricant doit soumettre une demande d\u2019homologation. Cette demande doit fournir aux organismes de r\u00e9glementation toutes les informations pertinentes obtenues lors des essais cliniques sur l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9 attendues du produit.<\/span><\/p>\n<h4><strong>Essais randomis\u00e9s contr\u00f4l\u00e9s (ECR)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Un essai randomis\u00e9 contr\u00f4l\u00e9 (\u00ab\u00a0randomized controlled trial\u00a0\u00bb ou RCT en anglais) est sans doute l&rsquo;un des moyens les plus rigoureux pour d\u00e9terminer s&rsquo;il existe une relation de cause \u00e0 effet entre un traitement et un r\u00e9sultat, et pour \u00e9valuer l\u2019efficacit\u00e9 d&rsquo;un traitement.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Des groupes comparables de sujets sont assign\u00e9s au hasard pour recevoir une nouvelle intervention m\u00e9dicale ou une intervention d\u00e9j\u00e0 standard (ou un placebo ou pas d\u2019intervention du tout). S&rsquo;ils sont en simple aveugle, le receveur ne sait pas \u00e0 quel groupe il a \u00e9t\u00e9 assign\u00e9. Si les essais sont en double aveugle, ceux qui administrent l&rsquo;intervention ne le savent pas non plus. Ce design permet des comparaisons entre les interventions et est consid\u00e9r\u00e9 comme l\u2019\u00e9talon or parmi les diff\u00e9rents types d\u2019\u00e9tudes dans le domaine m\u00e9dical.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Plus d&rsquo;informations ici : <\/span><span style=\"font-weight: 400;\">\u00a0<\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/9468688\/\"><span style=\"font-weight: 400;\">Understanding controlled trials. Why are randomised controlled trials important ?<\/span><\/a><span style=\"font-weight: 400;\"> (<\/span><span style=\"font-weight: 400;\">Comprendre les essais contr\u00f4l\u00e9s : pourquoi les essais contr\u00f4l\u00e9s randomis\u00e9s sont-ils importants?)<\/span><\/p>\n<h4><strong>\u00c9tudes r\u00e9trospectives<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Ces \u00e9tudes sont effectu\u00e9es en examinant des donn\u00e9es d\u00e9j\u00e0 collect\u00e9es dans le pass\u00e9. Les \u00e9tudes r\u00e9trospectives sont des \u00e9tudes observationnelles sujettes aux biais, car les donn\u00e9es n&rsquo;ont pas \u00e9t\u00e9 collect\u00e9es pour r\u00e9pondre \u00e0 la question de recherche sp\u00e9cifique de l\u2019\u00e9tude en question.<\/span><\/p>\n<h4><strong>Crit\u00e8re de substitution\u00a0<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Les crit\u00e8res de substitution sont des indicateurs (souvent des biomarqueurs) choisis par les chercheurs car ils sont consid\u00e9r\u00e9s comme des contributeurs importants au m\u00e9canisme d&rsquo;une maladie. Par exemple, la tension art\u00e9rielle peut \u00eatre utilis\u00e9e comme crit\u00e8re de substitution dans un essai sur des m\u00e9dicaments cardiovasculaires, car il s&rsquo;agit d&rsquo;un facteur de risque connu de crise cardiaque et d&rsquo;accident vasculaire c\u00e9r\u00e9bral. L&rsquo;hypoth\u00e8se est que si le m\u00e9dicament montre un effet sur le crit\u00e8re de substitution, l&rsquo;hypertension art\u00e9rielle, il aura \u00e9galement un effet sur le r\u00e9sultat clinique (crises cardiaques et accidents vasculaires c\u00e9r\u00e9braux). Malheureusement, dans de nombreux cas, l\u2019effet d\u2019un m\u00e9dicament sur un crit\u00e8re de substitution n\u2019apportera pas le b\u00e9n\u00e9fice escompt\u00e9 aux patients et peut m\u00eame leur nuire, car d\u2019autres aspects du m\u00e9canisme de la maladie n\u2019ont pas encore \u00e9t\u00e9 bien compris. C\u2019est pourquoi, tout r\u00e9sultat obtenu dans une \u00e9tude con\u00e7ue avec un crit\u00e8re de substitution doit \u00eatre appr\u00e9ci\u00e9 avec beaucoup de prudence.<\/span><\/p>\n<h4><strong>Organisation mondiale de la sant\u00e9 (OMS)<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">L&rsquo;OMS op\u00e8re sous l&rsquo;\u00e9gide des Nations Unies pour coordonner les r\u00e9ponses internationales en mati\u00e8re de sant\u00e9 publique. Bas\u00e9e \u00e0 Gen\u00e8ve, en Suisse, l&rsquo;agence compte six bureaux r\u00e9gionaux et 150 bureaux ext\u00e9rieurs dans le monde.<\/span><\/p>\n<h4><strong>Annexe B : Agences de r\u00e9glementation<\/strong><\/h4>\n<p><b>Am\u00e9rique du Nord<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u00c9tats-Unis:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.fda.gov\/\"><span style=\"font-weight: 400;\">Food and Drug Administration <\/span><\/a><span style=\"font-weight: 400;\">(FDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Canada :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.canada.ca\/en\/health-canada.html\"><span style=\"font-weight: 400;\">Sant\u00e9\u00a0 Canada\u00a0<\/span><\/a><\/li>\n<\/ul>\n<p><b>Am\u00e9rique Latine<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Argentine<\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.anmat.gov.ar\/principal.asp\"><span style=\"font-weight: 400;\">National Administration of Drugs, Food, and Medical Devices<\/span><\/a><span style=\"font-weight: 400;\"> (ANMAT)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">B\u00e9lize<\/span><span style=\"font-weight: 400;\"> :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.health.gov.bz\/moh\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Bolivie:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.minsalud.gob.bo\/\"><span style=\"font-weight: 400;\">Ministry of Health and Social Welfare<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Br\u00e9zil<\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/portal.anvisa.gov.br\/\"><span style=\"font-weight: 400;\">Brazilian Health Surveillance Agency <\/span><\/a><span style=\"font-weight: 400;\">(ANVISA)<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-weight: 400;\">Chilie<\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.ispch.cl\/\"><span style=\"font-weight: 400;\">Public Health Institute of Chile (ISPCH) <\/span><\/a><span style=\"font-weight: 400;\">(ISPCH)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Colombie <\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.minsalud.gov.co\/sites\/english\/Pages\/default.aspx\"><span style=\"font-weight: 400;\">Ministry of Health and Social Protection <\/span><\/a><span style=\"font-weight: 400;\">\/<\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.invima.gov.co\/\"><span style=\"font-weight: 400;\"> INVIMA <\/span><\/a><span style=\"font-weight: 400;\">Instituto Nacional de Vigilancia de Medicamentos y Alimentos<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Costa Rica<\/span><span style=\"font-weight: 400;\"> :<\/span><span style=\"font-weight: 400;\"> Ministry of Health<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Cuba <\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.cecmed.cu\/\"><span style=\"font-weight: 400;\">CECMED<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">\u00c9quateur<\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.controlsanitario.gob.ec\/\"><span style=\"font-weight: 400;\">National Agency for Regulation, Control, and Sanitary Surveillance<\/span><\/a><span style=\"font-weight: 400;\"> (ARCSA)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Salvador<\/span><span style=\"font-weight: 400;\"> :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.salud.gob.sv\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Guatemala<\/span><span style=\"font-weight: 400;\"> :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.mspas.gob.gt\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Guyanes<\/span><span style=\"font-weight: 400;\"> :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.health.gov.gy\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Jama\u00efque<\/span><span style=\"font-weight: 400;\"> :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.moh.gov.jm\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Mexique<\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.gob.mx\/cofepris\"><span style=\"font-weight: 400;\">Federal Commission for the Protection Against Sanitary Risk<\/span><\/a><span style=\"font-weight: 400;\"> (COFEPRIS)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Nicaragua<\/span><span style=\"font-weight: 400;\"> :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.minsa.gob.ni\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Panama <\/span><span style=\"font-weight: 400;\">:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.minsa.gob.pa\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Paraguay<\/span><span style=\"font-weight: 400;\"> :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.mspbs.gov.py\/portal\"><span style=\"font-weight: 400;\">Ministry of Public Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">P\u00e9rou :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.digemid.minsa.gob.pe\/\"><span style=\"font-weight: 400;\">General Directorate of Medicines, Supplies, and Drugs <\/span><\/a><span style=\"font-weight: 400;\">(DIGEMID)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Trinidad et Tobago:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.health.gov.tt\/\"><span style=\"font-weight: 400;\">Ministry of Health <\/span><\/a><span style=\"font-weight: 400;\">\/<\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.ttbs.org.tt\/\"><span style=\"font-weight: 400;\"> Bureau of Standards<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Uruguay :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.msp.gub.uy\/\"><span style=\"font-weight: 400;\">Ministry of Public Health<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Venezuela :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.inhrr.gob.ve\/\"><span style=\"font-weight: 400;\">National Institute of Hygiene \u201cRafael Rangel\u201d <\/span><\/a><span style=\"font-weight: 400;\">\/<\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sacs.gob.ve\/site\/\"><span style=\"font-weight: 400;\"> Autonomous Health Service Comptroller <\/span><\/a><span style=\"font-weight: 400;\">(SACS)<\/span><\/li>\n<\/ul>\n<h4><strong>Etats membres de l\u2019UE<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Il existe <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.fimea.fi\/web\/en\/marketing_authorisations\"><span style=\"font-weight: 400;\">plusieurs options pour demander une autorisation<\/span><\/a><span style=\"font-weight: 400;\"> de mise sur le march\u00e9 au sein de l&rsquo;UE.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Union<\/span> <span style=\"font-weight: 400;\">Europ\u00e9enne :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ema.europa.eu\/en\"><span style=\"font-weight: 400;\">European Medicines Agency <\/span><\/a><span style=\"font-weight: 400;\">(EMA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Autriche :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.basg.gv.at\/en\/\"><span style=\"font-weight: 400;\">Bundesamt f\u00fcr Sicherheit im Gesundheitswesen <\/span><\/a><span style=\"font-weight: 400;\">(BASG \/ AGES)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Belgique :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.famhp.be\/en\"><span style=\"font-weight: 400;\">Federal Agency for Medicines and Health Products<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bulgarie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.bda.bg\/?lang=en\"><span style=\"font-weight: 400;\">Bulgarian Drug Agency <\/span><\/a><span style=\"font-weight: 400;\">(BDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Croatie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.almp.hr\/\"><span style=\"font-weight: 400;\">Agency for Medicinal Products and Medical Devices of Croatia<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Chypre :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.moh.gov.cy\/moh\/moh.nsf\/index_en\/index_en?OpenDocument\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">R\u00e9publique Tch\u00e8que :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sukl.eu\/medicines\/marketing-authorisation-of-pharmaceuticals\"><span style=\"font-weight: 400;\">State Institute for Drug Control <\/span><\/a><span style=\"font-weight: 400;\">(SUKL)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Danemark :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/laegemiddelstyrelsen.dk\/en\/\"><span style=\"font-weight: 400;\">The Danish Medicines Agency<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Estonie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/ravimiamet.ee\/en\"><span style=\"font-weight: 400;\">Agency of Medicines\u00a0<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Finlande :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.fimea.fi\/en\/web\/en\/frontpage\"><span style=\"font-weight: 400;\">Finnish Medicines Agency <\/span><\/a><span style=\"font-weight: 400;\">(FIMEA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">France :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ansm.sante.fr\/\"><span style=\"font-weight: 400;\">Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9<\/span><\/a><span style=\"font-weight: 400;\"> (ANSM)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Allemagne :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.bfarm.de\/EN\/Home\/home_node.html\"><span style=\"font-weight: 400;\">Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte <\/span><\/a><span style=\"font-weight: 400;\">(BfArM)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Gr\u00e8ce :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.eof.gr\/web\/guest\/home\"><span style=\"font-weight: 400;\">National Organization for Medicines<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Hongrie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ogyei.gov.hu\/main_page\/\"><span style=\"font-weight: 400;\">National Institute for Pharmacy and Nutrition <\/span><\/a><span style=\"font-weight: 400;\">(OGYEI)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Irelande :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.hpra.ie\/\"><span style=\"font-weight: 400;\">Health Products Regulatory Authority <\/span><\/a><span style=\"font-weight: 400;\">(HPRA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Italie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.aifa.gov.it\/en\"><span style=\"font-weight: 400;\">Agenzia Italiana del Farmaco <\/span><\/a><span style=\"font-weight: 400;\">(AIFA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Lettonie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.zva.gov.lv\/en?setlang=en&amp;amp;large\"><span style=\"font-weight: 400;\">State Agency of Medicines<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Lituanie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.vvkt.lt\/index.php?3662774782\"><span style=\"font-weight: 400;\">State Medicines Control Agency <\/span><\/a><span style=\"font-weight: 400;\">(SMCA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Malte :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/medicinesauthority.gov.mt\/\"><span style=\"font-weight: 400;\">Medicines Authority<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Pays-Bas:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/english.cbg-meb.nl\/\"><span style=\"font-weight: 400;\">Medicines Evaluation Board <\/span><\/a><span style=\"font-weight: 400;\">(MEB)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Pologne:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.urpl.gov.pl\/en\/office\"><span style=\"font-weight: 400;\">Office\u00a0 for\u00a0 Registration\u00a0 of\u00a0 Medicinal \u00a0 Products,\u00a0 Medical\u00a0 Devices, and Biocidal Products <\/span><\/a><span style=\"font-weight: 400;\">(UPRL)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Portugal:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.infarmed.pt\/web\/infarmed-en\/\"><span style=\"font-weight: 400;\">National Authority of Medicines and Health Products <\/span><\/a><span style=\"font-weight: 400;\">(INFARMED)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Roumanie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.anm.ro\/\"><span style=\"font-weight: 400;\">The National Agency for Medicines and Medical Devices <\/span><\/a><span style=\"font-weight: 400;\">(NAMMD)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Slovaquie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sukl.sk\/\"><span style=\"font-weight: 400;\">State Institute for Drug Control<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Slov\u00e9nie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.jazmp.si\/\"><span style=\"font-weight: 400;\">Agency for Medicinal Products and Medical<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Espagne :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.msc.es\/en\/home.htm\"><span style=\"font-weight: 400;\">Ministry of Health, Social Services, and Equality<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Su\u00e8de :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/lakemedelsverket.se\/english\/\"><span style=\"font-weight: 400;\">Medical Products Agency <\/span><\/a><span style=\"font-weight: 400;\">(MPA)<\/span><\/li>\n<\/ul>\n<h4><strong>Etats non membres de l\u2019UE<\/strong><\/h4>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Albanie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.akbpm.gov.al\/\"><span style=\"font-weight: 400;\">National Agency on Drugs and Medical Devices\u00a0<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Andorre :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.salut.ad\/\"><span style=\"font-weight: 400;\">Ministry of Health and Welfare<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Arm\u00e9nie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.pharm.am\/index.php?langid=3\"><span style=\"font-weight: 400;\">Scientific Center of Drug and Medical Technologies Expertise<\/span><\/a><span style=\"font-weight: 400;\"> (SCDMTE)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Azerba\u00efdjan :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.pharma.az\/\"><span style=\"font-weight: 400;\">Center of Drug Analytical Expertise of the Ministry of Health of Azerbaijan<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bi\u00e9lorussie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.rceth.by\/\"><span style=\"font-weight: 400;\">Center for Examinations and Tests in Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bosnie-Herz\u00e9govine :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.almbih.gov.ba\/\"><span style=\"font-weight: 400;\">Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Georgie:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.moh.gov.ge\/en\/\"><span style=\"font-weight: 400;\">Ministry of Labor, Health, and Social Protection<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Islande :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.ima.is\/\"><span style=\"font-weight: 400;\">Icelandic Medicines Agency<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Kosovo :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/akppm.com\/en\"><span style=\"font-weight: 400;\">Kosovo Medicines Agency<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Mac\u00e9doine:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/malmed.gov.mk\/\"><span style=\"font-weight: 400;\">Agency for Medicinal Products and Medical Devices<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Mont\u00e9n\u00e9gro :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.calims.me\/Portal\/faces\/glavna.jspx\"><span style=\"font-weight: 400;\">Agency for Medicines and Medical Devices\u00a0<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Norv\u00e8ge :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/legemiddelverket.no\/english\"><span style=\"font-weight: 400;\">Norwegian Medicines Agency<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Russie:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.roszdravnadzor.ru\/\"><span style=\"font-weight: 400;\">Federal Service on Surveillance in Healthcare and Social Development<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Saint- Marin:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sanita.sm\/on-line\/home.html\"><span style=\"font-weight: 400;\">Ministry of Health and Social Security<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Serbie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.alims.gov.rs\/\"><span style=\"font-weight: 400;\">Medicines and Medical Devices Agency of Serbia<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Suisse :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home.html\"><span style=\"font-weight: 400;\">Swissmedic<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Royaume-Uni:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\"><span style=\"font-weight: 400;\">Medicines and Healthcare Products Regulatory Agency <\/span><\/a><span style=\"font-weight: 400;\">(MHRA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Ukraine:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/moz.gov.ua\/\"><span style=\"font-weight: 400;\">State Inspectorate for Quality Control of Medicines\u00a0<\/span><\/a><\/li>\n<\/ul>\n<h4><strong>Asie et Pacifique<\/strong><\/h4>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Australie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.tga.gov.au\/\"><span style=\"font-weight: 400;\">Therapeutic Goods Administration <\/span><\/a><span style=\"font-weight: 400;\">(TGA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bangladesh :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.dgda.gov.bd\/\"><span style=\"font-weight: 400;\">Directorate General of Drug Administration <\/span><\/a><span style=\"font-weight: 400;\">(DGDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bhoutan :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/dra.gov.bt\/\"><span style=\"font-weight: 400;\">Drug Regulatory Authority<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Chine :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.nmpa.gov.cn\/\"><span style=\"font-weight: 400;\">China Food and Drug Administration <\/span><\/a><span style=\"font-weight: 400;\">(SFDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Hong Kong:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.mdco.gov.hk\/eindex.html\"><span style=\"font-weight: 400;\">Department of Health \/ Central Drugs Standard Control Organization<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Inde :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\"><span style=\"font-weight: 400;\">Central Drugs Standard Control Organization<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Indon\u00e9sie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.qualtechs.com\/en-gb\/indonesia_registration\"><span style=\"font-weight: 400;\">Ministry of Health Medical Device Regulatory &amp; CRO<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Japon :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.pmda.go.jp\/english\/index.html\"><span style=\"font-weight: 400;\">Pharmaceuticals and Medical Devices Agency (PMDA)\/Ministry of Health, Labour and Welfare <\/span><\/a><span style=\"font-weight: 400;\">(MHLW)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Kyrgyzstan:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.pharm.kg\/\"><span style=\"font-weight: 400;\">Department of Medicines Supply and Medical Equipment of the Ministry of Health of the Republic of Kyrgyzstan<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Laos :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.fdd.gov.la\/\"><span style=\"font-weight: 400;\">Food and Drug Department<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Maldives :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/health.gov.mv\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Malaisie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/npra.moh.gov.my\/\"><span style=\"font-weight: 400;\">National Pharmaceutical Regulatory Agency <\/span><\/a><span style=\"font-weight: 400;\">(NPRA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">N\u00e9pal :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.dda.gov.np\/\"><span style=\"font-weight: 400;\">Department of Drug Administration<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Nouvelle Z\u00e9lande :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.medsafe.govt.nz\/\"><span style=\"font-weight: 400;\">New Zealand Medicines and Medical Devices Safety Authority<\/span><\/a><span style=\"font-weight: 400;\"> (MEDSAFE)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Pakistan:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.dra.gov.pk\/\"><span style=\"font-weight: 400;\">Drug Regulatory Authority of Pakistan<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Philippines :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.doh.gov.ph\/\"><span style=\"font-weight: 400;\">Department of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Singapour :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.hsa.gov.sg\/\"><span style=\"font-weight: 400;\">Health Sciences Authority<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Cor\u00e9e du Sud:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.mfds.go.kr\/eng\/index.do\"><span style=\"font-weight: 400;\">South Korea Ministry of Food and Drug Safety<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Sri Lanka:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.cdda.gov.lk\/\"><span style=\"font-weight: 400;\">Cosmetics, Devices, &amp; Drugs Regulatory Authority\u00a0<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Taiwan:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/newsser.fda.moph.go.th\/fda_mdc\/frontend\/theme_1\/index.php\"><span style=\"font-weight: 400;\">Taiwan Food and Drug Administration<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Tha\u00eflande:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.fda.moph.go.th\/Pages\/HomeP_D2.aspx\"><span style=\"font-weight: 400;\">Thailand Food and Drug Administration<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Vietnam:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.dav.gov.vn\/\"><span style=\"font-weight: 400;\">Drug Administration of \u00a0 Vietnam\u00a0 <\/span><\/a><span style=\"font-weight: 400;\">\/<\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/moh.gov.vn\/pages\/home.aspx\"><span style=\"font-weight: 400;\"> Medical Devices Department,<\/span><\/a> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/moh.gov.vn\/pages\/home.aspx\"><span style=\"font-weight: 400;\">\u00a0Ministry of Health<\/span><\/a><\/li>\n<\/ul>\n<h4><strong>Moyen-Orient<\/strong><\/h4>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bahre\u00efn :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.nhra.bh\/\"><span style=\"font-weight: 400;\">National Health Regulatory Authority<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Iran :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.behdasht.gov.ir\/\"><span style=\"font-weight: 400;\">Ministry\u00a0 of\u00a0 Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Iraq :<\/span><span style=\"font-weight: 400;\">\u00a0 <\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.moh.gov.iq\/index.php\"><span style=\"font-weight: 400;\">Ministry\u00a0 of\u00a0 Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Isra\u00ebl :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.health.gov.il\/english\/Pages\/HomePage.aspx\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Jordanie:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.jfda.jo\/Default.aspx\"><span style=\"font-weight: 400;\">Jordan Food and Drug Administration <\/span><\/a><span style=\"font-weight: 400;\">(JFDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Kowe\u00eft:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.kims.org.kw\/\"><span style=\"font-weight: 400;\">Kuwait Institute for Medical Specialization<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Liban :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.moph.gov.lb\/en\/\"><span style=\"font-weight: 400;\">Ministry of Public Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Maroc :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gov.ma\/Pages\/Accueil.aspx\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Oman:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.moh.gov.om\/en\/\"><span style=\"font-weight: 400;\">Ministry of Health Sultanate of Oman<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Qatar:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.moph.gov.qa\/english\/Pages\/default.aspx\"><span style=\"font-weight: 400;\">MOH Pharmacy and Drug Control Department<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Arabie Saoudite :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sfda.gov.sa\/En\/Pages\/default.aspx\"><span style=\"font-weight: 400;\">Saudi Food and Drug Authority <\/span><\/a><span style=\"font-weight: 400;\">(SFDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Syrie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.moh.gov.sy\/Default.aspx?tabid=257&amp;amp;language=en-US\"><span style=\"font-weight: 400;\">Directorate of Drug Control<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Turquie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.titck.gov.tr\/\"><span style=\"font-weight: 400;\">Turkish Medicines and Medical Devices Agency<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Emirats Arabe Unis :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.moh.gov.ae\/en\/Pages\/default.aspx\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Y\u00e9men :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sbd-ye.org\/\"><span style=\"font-weight: 400;\">Supreme Commission for Drugs and Medical Appliances<\/span><\/a><\/li>\n<\/ul>\n<h4><strong>Afrique<\/strong><\/h4>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Alg\u00e9rie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.dz\/\"><span style=\"font-weight: 400;\">Ministry of Health, Population, and Hospitals<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Angola: Direc\u00e7\u00e3o Nacional de Medicamentos e Equipamentos \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.minsa.gov.ao\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">B\u00e9nin : <\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/dpmed-benin.bj\/\"><span style=\"font-weight: 400;\">Direction de la Pharmacie et des explorations diagnostics<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Botswana:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.moh.gov.bw\/drug_regulation.html\"><span style=\"font-weight: 400;\">Drug Regulatory Services \/ Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Burkina Faso :<\/span> <span style=\"font-weight: 400;\">Direction G\u00e9n\u00e9rale de la Pharmacie, du M\u00e9dicament et des<\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gov.bf\/index.php?option=com_content&amp;amp;view=article&amp;amp;id=188&amp;amp;Itemid=1032\"><span style=\"font-weight: 400;\"> Laboratoire<\/span><\/a><span style=\"font-weight: 400;\">s<\/span><span style=\"font-weight: 400;\"> (DPMED)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Burundi :<\/span><span style=\"font-weight: 400;\"> Direction de la pharmacie, du m\u00e9dicament et des laboratoires <\/span><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Cap Vert:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.eris.cv\/index.php\/component\/content\/?view=featured\"><span style=\"font-weight: 400;\">Entidade Reguladora Independente da Sa\u00fade <\/span><\/a><span style=\"font-weight: 400;\">(ERIS)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Cameroun :<\/span><span style=\"font-weight: 400;\"> Direction \u00a0 de\u00a0 \u00a0 la Pharmacie, du\u00a0 M\u00e9dicament \u00a0 et des Laboratoire <\/span><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Tchad :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/sante-tchad.org\/portfolio-items\/direction-de-la-pharmacie-du-medicament-et-de-la-pharmacopee\/\"><span style=\"font-weight: 400;\">Direction de la pharmacie, du m\u00e9dicament et de la pharmacop\u00e9e <\/span><\/a><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Congo : Direction des pharmacies, du m\u00e9dicament et des laboratoires \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.congo-info.com\/minister\/56\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">C\u00f4te d\u2019Ivoire :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.dpml.ci\/\"><span style=\"font-weight: 400;\">Direction de la pharmacie, du m\u00e9dicament et des laboratoires<\/span><\/a><span style=\"font-weight: 400;\"> (DPML) \/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">RDC :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/dpmrdc.org\/\"><span style=\"font-weight: 400;\">Direction de la pharmacie et du m\u00e9dicament <\/span><\/a><span style=\"font-weight: 400;\">(DPM) \/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Djibouti :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gouv.dj\/Les%20directions.htm\"><span style=\"font-weight: 400;\">Direction du m\u00e9dicament, de la pharmacie et des laboratoires<\/span><\/a><span style=\"font-weight: 400;\"> (DMPL) \/<\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gouv.dj\/Les%20directions.htm\"><span style=\"font-weight: 400;\"> Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u00c9gypte :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/eda.mohp.gov.eg\/\"><span style=\"font-weight: 400;\">Egyptian Drug Authority <\/span><\/a><span style=\"font-weight: 400;\">(EDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Guin\u00e9e \u00c9quatoriale : Direction g\u00e9n\u00e9rale de pharmacie et m\u00e9decine traditionnelle \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.guineaecuatorialpress.com\/m\/noticia.php?id=126&amp;amp;lang=fr\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u00c9rythr\u00e9e: National Medicine and Food Administration \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.moh.gov.sa\/en\/Ministry\/Pages\/default.aspx\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u00c9thiopie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.fmhaca.gov.et\/\"><span style=\"font-weight: 400;\">Ethiopian Food and Drug Authority <\/span><\/a><span style=\"font-weight: 400;\">(EFDA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Gabon : Direction du m\u00e9dicament et de la pharmacie \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gouv.ga\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Gambie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.mca.gm\/\"><span style=\"font-weight: 400;\">Medicine Control Agency <\/span><\/a><span style=\"font-weight: 400;\">(MCA) \/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Ghana :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.fdaghana.gov.gh\/\"><span style=\"font-weight: 400;\">Food and Drugs Authority<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">R\u00e9publique de Guin\u00e9e : Direction nationale de la pharmacie et du laboratoire\/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/sante.gov.gn\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Guin\u00e9e-Bissau :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.guinebissaurepublic.com\/health-2\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Kenya:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/pharmacyboardkenya.org\/\"><span style=\"font-weight: 400;\">Pharmacy and Poisons Board <\/span><\/a><span style=\"font-weight: 400;\">(PBD)<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Lesotho :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.gov.ls\/ministry-of-health\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Lib\u00e9ria : Liberia Medicines and Health Products Regulatory Authority \/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Libye : Pharmacy Management Department \/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Madagascar : Direction de la pharmacie, des laboratoires et de la m\u00e9decine traditionnelle \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gov.mg\/home\/n\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Malawi: Pharmacy, Medicines, and Poisons Board \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.health.gov.mw\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Mali : Direction de la pharmacie et des m\u00e9dicaments \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gov.ml\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Mauritanie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.sante.gov.ma\/Pages\/ADM_Centrale\/DMP.aspx\"><span style=\"font-weight: 400;\">Direction des m\u00e9dicaments et de la pharmacie <\/span><\/a><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Maurice: Pharmacy Board \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/health.govmu.org\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Maroc :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/dmp.sante.gov.ma\/\"><span style=\"font-weight: 400;\">Direction du m\u00e9dicament et de la pharmacie <\/span><\/a><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Mozambique:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.arm.co.mz\/\"><span style=\"font-weight: 400;\">Direc\u00e7\u00e3o Nacional de Farm\u00e1cia <\/span><\/a><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Namibie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.nmrc.com.na\/\"><span style=\"font-weight: 400;\">Namibia Medicines Regulatory Council <\/span><\/a><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Niger : Direction de la pharmacie, des laboratoires et de la pharmacop\u00e9e traditionnelle \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.sante.gouv.ne\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Nig\u00e9ria:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.nafdac.gov.ng\/\"><span style=\"font-weight: 400;\">National Agency for Food and Drug Administration and Control<\/span><\/a><span style=\"font-weight: 400;\"> (NAFDAC)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Rwanda: Department of Pharmaceutical Services \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/moh.gov.rw\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">S\u00e3o Tom\u00e9 et Pr\u00edncipe : Direction de la pharmacie et du m\u00e9dicament \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/ms.gov.st\/\"><span style=\"font-weight: 400;\">Ministry of\u00a0 \u00a0 \u00a0 \u00a0 Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">S\u00e9n\u00e9gal :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.dirpharm.net\/\"><span style=\"font-weight: 400;\">Direction de la pharmacie et du m\u00e9dicament <\/span><\/a><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Seychelles: Medicines Regulation Unit \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.health.gov.sc\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Sierra L\u00e9one : Pharmacy Board of Sierra Leone \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/mohs.gov.sl\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Somalie: Pharmaceutical and Medical Department \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/moh.gov.so\/en\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Afrique du Sud:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.sahpra.org.za\/\"><span style=\"font-weight: 400;\">South African Health Products Regulatory Authority <\/span><\/a><span style=\"font-weight: 400;\">(SAHPRA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Soudan du Sud: Food and Drugs \u00a0 Control\u00a0 Authority, South Sudan \/ <\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.nmpb.gov.sd\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Soudan:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.nmpb.gov.sd\/\"><span style=\"font-weight: 400;\">National Medicine and Poisons Board<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Swaziland: Pharmaceutical Services Department \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.gov.sz\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Togo : <\/span><span style=\"font-weight: 400;\">\u00a0<\/span><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.service-public.gouv.tg\/service-concern%C3%A9\/direction-de-la-pharmacie-du-m%C3%A9dicament-et-des-laboratoires?page=1\"><span style=\"font-weight: 400;\">Direction \u00a0 de\u00a0 la\u00a0 pharmacie, du\u00a0 m\u00e9dicament\u00a0 et \u00a0 \u00a0 des\u00a0 laboratoires <\/span><\/a><span style=\"font-weight: 400;\">\/ Ministry of Health<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Tanzanie: Tanzania Food and Drug Authority (TFDA) \/<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.moh.go.tz\/en\/\"><span style=\"font-weight: 400;\">Ministry of Health<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Tunisie :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.dpm.tn\/index.php\/medicament\/reglementation\"><span style=\"font-weight: 400;\">Direction de la pharmacie et du m\u00e9dicament <\/span><\/a><span style=\"font-weight: 400;\">(DPM)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Ouganda :<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.nda.or.ug\/\"><span style=\"font-weight: 400;\">National Drug Authority<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Zambie:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.zamra.co.zm\/\"><span style=\"font-weight: 400;\">Zambia Medicines Regulatory Authority <\/span><\/a><span style=\"font-weight: 400;\">(ZAMRA)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Zimbabwe:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.mcaz.co.zw\/\"><span style=\"font-weight: 400;\">Medicines Control Authority <\/span><\/a><span style=\"font-weight: 400;\">(MCAZ)<\/span><\/li>\n<\/ul>\n<h4><strong>Annexe C :\u00a0Ouvrages de r\u00e9f\u00e9rence\u00a0<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Marcia Angell, M.D., \u201cThe Truth About Drug Companies: How They Deceive Us and What to Do About It.\u201d (2004)\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Michael Blastland, Andrew Dilnot, \u201cThe Tiger That Isn\u2019t: Seeing Through A World Of Numbers.\u201d (2007)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Nellie Bly, \u201cTen Days in a Mad-House.\u201d (1887)<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\"> Douglas Bremner, M.D., \u201cBefore You Take That Pill.\u201d (2008)\u00a0<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Daniel Carpenter, \u201cReputation and Power : Organizational Image and Pharmaceutical Regulation at the FDA.\u201d (2010)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">John Carreyrou, \u201cBad Blood: Secrets and Lies in a Silicon Valley Startup.\u201d (2018)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Archie L. Cochrane, \u201cEffectiveness And Efficiency: Random Reflections on Health Services.\u201d (1972)\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Katherine Eban, \u201cBottle of Lies: The Inside Story of the Generic Drug Boom.\u201d (2019)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Allen Frances, \u201cSaving Normal: An Insider&rsquo;s Revolt against Out-of-Control Psychiatric Diagnosis, DSM-5, Big Pharma, and the Medicalization of Ordinary Life.\u201d (2014)\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Gerd Gigerenzer, \u201cCalculated risks: How to Know When Numbers Deceive You.\u201d (2003)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Gerd Gigerenzer, \u201cReckoning With Risk : Learning to Live With Uncertainty.\u201d (2002)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ben Goldacre, \u201cBad Pharma: How Medicine is Broken, and How We Can Fix It.\u201d (2012)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Merrill Goozner, \u201cThe $800 Million Pill: The Truth Behind the Cost of New Drugs.\u201d (2005)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Peter C. G\u00f8tzsche, \u201cMammography Screening : Truth, Lies and Controversy.\u201d (2012)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Peter C. G\u00f8tzsche, \u201cDeadly Medicines and Organised Crime : How Big Pharma Has Corrupted Healthcare.\u201d (2013)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Katharine Greider, \u201cThe Big Fix : How the Pharmaceutical Industry Rips Off American Consumers.\u201d (2003)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Iona Heath, \u201cMatters of Life and Death: Key Writings.\u201d (2007)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Darrell Huff, \u201cHow To Lie with Statistics.\u201d (1954)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Jon Jureidini, Leemon B. Mchenry, \u201cThe Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research.\u201d (2020)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Robert M. Kaplan, \u201cDisease, Diagnoses, and Dollars: Facing the Ever-Expanding Market for Medical Care.\u201d (2009)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Jerome P. Kassirer, M.D., \u201cOn The Take: How Medicine\u2019s Complicity with Big Business Can Endanger Your Health.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">James Le Fanu, \u201cThe Rise and Fall of Modern Medicine.\u201d (2000) Jacky Law, \u201cBig Pharma : How The World\u2019s Biggest Drug Companies Control Illness.\u201d (2006)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">John Le Carr\u00e9, \u201cThe Constant Gardener.\u201d (2005)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Jeanne Lenzer, \u201cThe Danger Within Us : America&rsquo;s Untested, Unregulated Medical Device Industry and One Man&rsquo;s Battle to Survive It.\u201d (2017)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Barry Meier, \u201cPain Killer : An Empire of Deceit and the Origin of America\u2019s Opioid Epidemic.\u201d (2018)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ray Moynihan, Alan Cassels, \u201cSelling Sickness: How the World\u2019s Biggest Pharmaceutical Companies Are Turning Us All into Patients.\u201d (2006)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Siddhartha Mukherjee, \u201cThe Laws of Medicine: Field Notes from an Uncertain Science.\u201d (2015)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Vinayak K. Prasad, Adam S. Cifu, \u201cEnding Medical Reversal : Improving Outcomes, Saving Lives.\u201d (2015)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Vinayak K. Prasad, \u201cMalignant: How Bad Policy and Bad Evidence Harm People with Cancer.\u201d (2020)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Marc A. Rodwin, \u201cConflicts of Interest and the Future of Medicine.\u201d (2011)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Peter Rost, \u201cThe Whistleblower : Confessions of a Healthcare Hitman.\u201d (2006)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Sergio Sismondo, \u201cGhost-Managed Medicine : Big Pharma&rsquo;s Invisible Hands.\u201d (2018)<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\"> Gilbert Welch, \u201cShould I Be Tested for Cancer ? : Maybe Not and Here&rsquo;s Why.\u201d (2006)<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> Gilbert Welch, Lisa Schwartz, Steve Woloshin, \u201cOverdiagnosed: Making People Sick in the Pursuit of Health.\u201d (2012)<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Steven Woloshin, Lisa M. Schwartz, H. Gilbert Welch, \u201cKnow Your Chances : Understanding Health Statistics.\u201d (2008)<\/span><\/p>\n<h4><strong>Note sur les auteurs\u00a0<\/strong><\/h4>\n<p><span style=\"font-weight: 400;\">Serena Tinari et Catherine Riva sont des journalistes d\u2019enqu\u00eate sp\u00e9cialis\u00e9es dans le domaine m\u00e9dical et les fondatrices de <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.re-check.ch\/wordpress\/en\/home_en\/\"><span style=\"font-weight: 400;\">Re-Check.ch<\/span><\/a><span style=\"font-weight: 400;\">, une organisation suisse \u00e0 but non lucratif qui investigue et cartographie les affaires de sant\u00e9. Re-Check.ch publie des articles dans plusieurs langues, \u00e9paule les r\u00e9dactions dans leurs enqu\u00eates de sant\u00e9 et organise des ateliers sur les m\u00e9thodes qui permettent de mener des recherches approfondies sur les questions m\u00e9dicales et la sant\u00e9 publique.<\/span><\/p>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.serenatinari.com\/\"><span style=\"font-weight: 400;\">Serena <\/span><span style=\"font-weight: 400;\">Tinari<\/span><\/a><span style=\"font-weight: 400;\"> travaille pour la presse, la radio et la t\u00e9l\u00e9vision depuis 1994. Elle est l&rsquo;auteure de dizaines d\u2019enqu\u00eates men\u00e9es pour la t\u00e9l\u00e9vision publique suisse. Serena Tinari est sp\u00e9cialis\u00e9e dans la s\u00e9curit\u00e9 des m\u00e9dicaments, la m\u00e9decine fond\u00e9e sur les preuves et les conflits d&rsquo;int\u00e9r\u00eats. Formatrice, conf\u00e9renci\u00e8re et mod\u00e9ratrice, elle a beaucoup enqu\u00eat\u00e9 sur la grippe H1N1 et le Tamiflu.<\/span><\/p>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"http:\/\/www.catherineriva.com\/\"><span style=\"font-weight: 400;\">Catherine <\/span><span style=\"font-weight: 400;\">Riva<\/span><\/a><span style=\"font-weight: 400;\"> est sp\u00e9cialis\u00e9e dans le design et la m\u00e9thodologie des essais cliniques, la sant\u00e9 publique et la m\u00e9decine fond\u00e9e sur les preuves. Formatrice et conf\u00e9renci\u00e8re, elle a enqu\u00eat\u00e9 sur l\u2019affaire Mediator, les programmes de d\u00e9pistage du cancer du sein, les controverses li\u00e9es \u00e0 la vaccination anti-HPV et les conflits d&rsquo;int\u00e9r\u00eats dans le domaine de la sant\u00e9 et la recherche m\u00e9dicale. Elle a \u00e9galement publi\u00e9 dans des revues biom\u00e9dicales.<\/span><\/p>\n<hr \/>\n<p><em>Le<strong> R\u00e9seau international de journalisme d&rsquo;investigation (GIJN)<\/strong> regroupe 211 organisations bas\u00e9es dans 82 pays qui soutiennent et consolident le journalisme d\u2019investigation autour du monde. L\u2019objectif de notre r\u00e9seau est de consolider la formation et le partage d\u2019information et de contacts parmi les journalistes d\u2019investigation et les data journalistes.\u00a0<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Annexe A : glossaire des termes D\u00e9claration d\u2019effets ind\u00e9sirables\u00a0 Signalements fournis par les patients et les professionnels de sant\u00e9 aux organismes de r\u00e9glementation nationaux et internationaux concernant les effets ind\u00e9sirables de m\u00e9dicaments et de dispositifs m\u00e9dicaux. Voir, par exemple, le syst\u00e8me de la FDA aux Etats-Unis. Biomarqueurs Les marqueurs biologiques font r\u00e9f\u00e9rence \u00e0 une large [&hellip;]<\/p>\n","protected":false},"author":3031133,"featured_media":1060093,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"republication-tracker-tool-hide-widget":false,"footnotes":"","_tec_slr_enabled":"","_tec_slr_layout":""},"categories":[23095,23094,23092],"tags":[],"gijn_topic":[],"series":[],"gijn_language":[17629,19911,17784],"gijn_region":[],"class_list":["post-322510","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-chapitre","category-guide-fr","category-ressource","gijn_language-en","gijn_language-en-fr","gijn_language-fr-fr"],"acf":[],"ticketed":false,"_links":{"self":[{"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/posts\/322510","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/users\/3031133"}],"replies":[{"embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/comments?post=322510"}],"version-history":[{"count":1,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/posts\/322510\/revisions"}],"predecessor-version":[{"id":1223004,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/posts\/322510\/revisions\/1223004"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/media\/1060093"}],"wp:attachment":[{"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/media?parent=322510"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/categories?post=322510"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/tags?post=322510"},{"taxonomy":"gijn_topic","embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/gijn_topic?post=322510"},{"taxonomy":"series","embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/series?post=322510"},{"taxonomy":"gijn_language","embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/gijn_language?post=322510"},{"taxonomy":"gijn_region","embeddable":true,"href":"https:\/\/gijn.org\/fr\/wp-json\/wp\/v2\/gijn_region?post=322510"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}