{"id":57144,"date":"2022-05-27T12:10:19","date_gmt":"2022-05-27T10:10:19","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/introduction-aux-bonnes-pratiques-de-fabrication-dans-lue\/"},"modified":"2022-05-27T12:10:19","modified_gmt":"2022-05-27T10:10:19","slug":"introduction-aux-bonnes-pratiques-de-fabrication-dans-lue","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/introduction-aux-bonnes-pratiques-de-fabrication-dans-lue\/","title":{"rendered":"Introduction aux Bonnes Pratiques de Fabrication dans l\u2019UE"},"content":{"rendered":"<p>En commen\u00e7ant par les fondements de l\u2019industrie pharmaceutique, qui b\u00e9n\u00e9ficie d\u2019une forte repr\u00e9sentation en Europe, ce cours souligne l\u2019importance des Bonnes Pratiques de Fabrication (BPF) pour garantir que les produits alimentaires, de sant\u00e9 et cosm\u00e9tiques sont s\u00fbrs et efficaces. L\u2019\u00e9volution du concept pour inclure les Bonnes Pratiques de Fabrication Actuelles (BPFa) et les Bonnes Pratiques de Fabrication Automatis\u00e9e (GAMP), qui emploient respectivement des proc\u00e9dures actualis\u00e9es et des technologies automatis\u00e9es, t\u00e9moigne de la nature progressive de l\u2019industrie pharmaceutique et de ses agences de r\u00e9glementation dans l\u2019Union europ\u00e9enne (UE). <\/p>\n<p>&nbsp;<\/p>\n<p>Dans ce cours, nous proposons une synth\u00e8se du sujet \u00e0 travers une exp\u00e9rience interactive en ligne. Ce support a \u00e9t\u00e9 con\u00e7u par une \u00e9quipe d\u2019experts en affaires r\u00e9glementaires dipl\u00f4m\u00e9s de l\u2019Universit\u00e9 Northeastern de Boston, pilot\u00e9e par un membre senior capable d\u2019articuler la th\u00e9orie avec la pratique. <\/p>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Introduction \u00e0 l\u2019industrie pharmaceutique<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>EFPIA \u2013 L\u2019organisation m\u00e8re de l\u2019industrie<\/li>\n<li>Petit, mais g\u00e9ant<\/li>\n<li>L\u2019Europe comme centre de R&#038;D<\/li>\n<li>L\u2019importance de la R&#038;D dans le secteur pharmaceutique<\/li>\n<li>Le commerce des produits pharmaceutiques dans l\u2019UE et la cha\u00eene de valeur mondiale<\/li>\n<li>Analyse des principaux enjeux commerciaux pour l\u2019industrie pharmaceutique europ\u00e9enne<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Introduction aux Bonnes Pratiques de Fabrication (BPF)<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Les 5 composantes des BPF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : Quelle est la diff\u00e9rence entre BPF et BPFa ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : R\u00e9glementations dans l\u2019UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Le r\u00f4le de l\u2019EMA<\/li>\n<li>Autorit\u00e9s nationales comp\u00e9tentes<\/li>\n<li>Autorisation et surveillance des fabricants<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 5 : Surveillance de la s\u00e9curit\u00e9 des m\u00e9dicaments<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Essais cliniques<\/li>\n<li>Coop\u00e9ration internationale<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 6 : Que sont les normes BPF ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Qu\u2019est-ce que le GAMP ?<\/li>\n<li>Qu\u2019est-ce que la validation des syst\u00e8mes informatis\u00e9s ?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 7 : R\u00e9glementations et lignes directrices des BPF de l\u2019UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 8 : Conformit\u00e9 aux BPF dans l\u2019UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Vaccins COVID-19 : d\u00e9veloppement, \u00e9valuation, approbation et surveillance dans l\u2019UE<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 9 : Cadre r\u00e9glementaire robuste et expertise scientifique dans l\u2019UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Processus d\u2019\u00e9valuation scientifique et d\u2019approbation<\/li>\n<li>\u00c9valuation acc\u00e9l\u00e9r\u00e9e<\/li>\n<li>Surveillance standard<\/li>\n<li>Surveillance \u00e0 grande \u00e9chelle dans le contexte de la pand\u00e9mie<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Examen final<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Certification<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>En commen\u00e7ant par les fondements de l\u2019industrie pharmaceutique, qui b\u00e9n\u00e9ficie d\u2019une forte repr\u00e9sentation en Europe, ce cours souligne l\u2019importance des Bonnes Pratiques de Fabrication (BPF) pour garantir que les produits alimentaires, de sant\u00e9 et cosm\u00e9tiques sont s\u00fbrs et efficaces. L\u2019\u00e9volution du concept pour inclure les Bonnes Pratiques de Fabrication Actuelles (BPFa) et les Bonnes Pratiques [&hellip;]<\/p>\n","protected":false},"featured_media":43192,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,257,254,258],"product_tag":[],"class_list":{"0":"post-57144","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-assurance-qualite","8":"product_cat-bpf-bonnes-pratiques-de-fabrication","9":"product_cat-pharmaceutique","11":"first","12":"instock","13":"taxable","14":"shipping-taxable","15":"purchasable","16":"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 v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bonnes Pratiques de Fabrication (BPF) dans l\u2019UE : cours certifi\u00e9 en ligne<\/title>\n<meta name=\"description\" content=\"Apprenez la conformit\u00e9 aux Bonnes Pratiques de Fabrication (BPF) dans l\u2019UE. 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