{"id":62383,"date":"2026-09-02T14:16:29","date_gmt":"2026-09-02T12:16:29","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/la-procedure-decentralisee-dcp\/"},"modified":"2026-09-03T10:36:38","modified_gmt":"2026-09-03T08:36:38","slug":"la-procedure-decentralisee-dcp","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/la-procedure-decentralisee-dcp\/","title":{"rendered":"La proc\u00e9dure d\u00e9centralis\u00e9e (DCP)"},"content":{"rendered":"<p>Lancer un m\u00e9dicament dans 27 pays europ\u00e9ens en m\u00eame temps, c\u2019est une course contre un d\u00e9lai de 210 jours. Une validation \u00e9chou\u00e9e ou une objection non r\u00e9solue d\u2019un \u00c9tat membre concern\u00e9 peut vous co\u00fbter un an. La proc\u00e9dure d\u00e9centralis\u00e9e (DCP), d\u00e9finie par la directive 2001\/83\/CE, est la voie vers une autorisation de mise sur le march\u00e9 dans l\u2019EEE pour un m\u00e9dicament jamais autoris\u00e9 en Europe auparavant : un \u00c9tat membre de r\u00e9f\u00e9rence \u00e9value, chaque \u00c9tat membre concern\u00e9 approuve. Cette formation en ligne de 2 heures transforme la proc\u00e9dure en une m\u00e9thode claire, du choix de votre \u00c9tat membre de r\u00e9f\u00e9rence aux variations qui suivent l\u2019approbation.   <\/p>\n<p>En dix le\u00e7ons, ce cours certifi\u00e9 couvre chaque \u00e9tape de la DCP \u00e0 partir de cas r\u00e9glementaires r\u00e9els, du fondement juridique et de l\u2019\u00e9ligibilit\u00e9 aux g\u00e9n\u00e9riques, \u00e0 la maintenance du cycle de vie et \u00e0 la DCP par rapport \u00e0 la MRP. Son certificat tra\u00e7able vous apporte une preuve pr\u00eate pour audit que vous, ou votre \u00e9quipe, \u00eates pr\u00eats \u00e0 appliquer la proc\u00e9dure d\u00e9centralis\u00e9e en pratique. <\/p>\n<p>&nbsp;&nbsp;<\/p>\n<p><strong>Pourquoi les \u00e9quipes choisissent ce cours<\/strong><\/p>\n<ul>\n<li>Con\u00e7u avec des experts europ\u00e9ens en <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/affaires-reglementaires-pharmaceutiques\/\">affaires r\u00e9glementaires<\/a>, int\u00e9grant les attentes des \u00e9valuateurs dans chaque le\u00e7on<\/li>\n<li>Chaque r\u00e8gle s\u2019appuie sur un incident r\u00e9el, du retrait de la thalidomide aux mesures de contr\u00f4le de l\u2019int\u00e9grit\u00e9 des donn\u00e9es des ann\u00e9es 2010, pour une m\u00e9morisation durable<\/li>\n<li>Couvre le cycle de vie complet, pas seulement du jour 0 au jour 210 : phase nationale, variations, renouvellements et \u00ab repeat-use \u00bb<\/li>\n<li>Deux heures intensives, \u00e0 votre rythme, avec une vid\u00e9o narr\u00e9e, des blocs interactifs et un contr\u00f4le des connaissances dans chaque le\u00e7on<\/li>\n<li>Un an d\u2019acc\u00e8s en autonomie par apprenant, avec un certificat de formation continue que votre AQ peut v\u00e9rifier en ligne<\/li>\n<\/ul>\n<p>&nbsp;&nbsp;<\/p>\n<p><strong>Ce que vous apprendrez<\/strong><\/p>\n<ul>\n<li>Situer la DCP parmi les quatre voies d\u2019une autorisation de mise sur le march\u00e9 europ\u00e9enne et la choisir plut\u00f4t que la MRP lorsqu\u2019elle est adapt\u00e9e<\/li>\n<li>Cartographier les r\u00f4les du demandeur, de l\u2019\u00c9tat membre de r\u00e9f\u00e9rence, des \u00c9tats membres concern\u00e9s et du CMDh<\/li>\n<li>S\u00e9lectionner le bon \u00c9tat membre de r\u00e9f\u00e9rence et pr\u00e9parer, soumettre et valider un dossier conforme via le CESP<\/li>\n<li>Parcourez le calendrier du Jour 0 au Jour 210 et g\u00e9rez l\u2019arr\u00eat du chronom\u00e8tre ainsi que vos r\u00e9ponses<\/li>\n<li>R\u00e9soudre les d\u00e9saccords par un recours au CMDh et un arbitrage au titre de l\u2019article 29(4) sans perdre la proc\u00e9dure<\/li>\n<li>Appliquer les r\u00e8gles relatives aux g\u00e9n\u00e9riques et hybrides, y compris la bio\u00e9quivalence et l\u2019exclusivit\u00e9 des donn\u00e9es, au sein d\u2019une DCP<\/li>\n<li>Constituer un dossier et un dossier de proc\u00e9dure capables de r\u00e9sister \u00e0 l\u2019examen et \u00e0 l\u2019inspection des autorit\u00e9s nationales comp\u00e9tentes<\/li>\n<\/ul>\n<p>&nbsp;&nbsp;<\/p>\n<p><strong>\u00c0 qui s\u2019adresse cette formation<\/strong><\/p>\n<ul>\n<li>Responsables des affaires r\u00e9glementaires et \u00e9quipes de soumission planifiant un lancement europ\u00e9en<\/li>\n<li>Sp\u00e9cialistes <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/cmc-chimie-fabrication-et-controles\/\">CMC<\/a>, cliniques et de <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/gestion-des-rapports-periodiques-actualises-de-securite-psur\/\">pharmacovigilance<\/a> contribuant \u00e0 un dossier DCP<\/li>\n<li>Chefs de projet et strat\u00e8ges r\u00e9glementaires choisissant entre les voies europ\u00e9ennes<\/li>\n<li>\u00c9quipes qualit\u00e9 et conformit\u00e9 assurant le maintien des autorisations apr\u00e8s approbation<\/li>\n<\/ul>\n<p>&nbsp;&nbsp;<\/p>\n<p>\u00c0 l\u2019issue de la formation, chaque apprenant re\u00e7oit un<strong> certificat valid\u00e9 accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 aux audits et \u00e0 la documentation de conformit\u00e9.<\/p>\n<p>&nbsp;&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p><strong>Le\u00e7on : br\u00e8ve histoire de l\u2019autorisation des m\u00e9dicaments en Europe<\/strong><\/p>\n<p><strong>Le\u00e7on 1 : le paysage des autorisations de mise sur le march\u00e9 en Europe<\/strong><\/p>\n<p><strong>Le\u00e7on 2 : base juridique, champ d\u2019application et \u00e9ligibilit\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on 3 : les acteurs cl\u00e9s et le choix de votre \u00c9tat membre de r\u00e9f\u00e9rence<\/strong><\/p>\n<p><strong>Le\u00e7on 4 : pr\u00e9paration et soumission de la demande<\/strong><\/p>\n<p><strong>Le\u00e7on 5 : \u00e9tape 1, phase d\u2019\u00e9valuation du jour 0 au jour 120<\/strong><\/p>\n<p><strong>Le\u00e7on 6 : \u00e9tape 2, parvenir \u00e0 un accord du jour 120 au jour 210<\/strong><\/p>\n<p><strong>Le\u00e7on 7 : en cas d\u2019\u00e9chec du consensus, saisine et arbitrage<\/strong><\/p>\n<p><strong>Le\u00e7on 8 : la phase nationale et l\u2019octroi de l\u2019autorisation<\/strong><\/p>\n<p><strong>Le\u00e7on 9 : les g\u00e9n\u00e9riques et la proc\u00e9dure d\u00e9centralis\u00e9e<\/strong><\/p>\n<p><strong>Le\u00e7on 10 : cycle de vie, harmonisation et DCP versus MRP<\/strong><\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>\u00c9valuation finale<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lancer un m\u00e9dicament dans 27 pays europ\u00e9ens en m\u00eame temps, c\u2019est une course contre un d\u00e9lai de 210 jours. Une validation \u00e9chou\u00e9e ou une objection non r\u00e9solue d\u2019un \u00c9tat membre concern\u00e9 peut vous co\u00fbter un an. La proc\u00e9dure d\u00e9centralis\u00e9e (DCP), d\u00e9finie par la directive 2001\/83\/CE, est la voie vers une autorisation de mise sur le [&hellip;]<\/p>\n","protected":false},"featured_media":62384,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,258],"product_tag":[],"class_list":{"0":"post-62383","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-pharmaceutique","9":"first","10":"instock","11":"virtual","12":"taxable","13":"purchasable","14":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Proc\u00e9dure d\u00e9centralis\u00e9e (DCP) \u2013 Formation certifi\u00e9e pour professionnels<\/title>\n<meta name=\"description\" content=\"Formation certifi\u00e9e sur la proc\u00e9dure d\u00e9centralis\u00e9e (DCP) pour les sciences de la vie, align\u00e9e sur la directive 2001\/83\/CE. 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