{"id":11071,"date":"2026-01-29T11:00:16","date_gmt":"2026-01-29T10:00:16","guid":{"rendered":"https:\/\/oytec.es\/ema-i-fda-els-10-principis-de-la-ia-farmaceutica\/"},"modified":"2026-10-17T17:26:34","modified_gmt":"2026-10-17T15:26:34","slug":"ema-i-fda-els-10-principis-de-la-ia-farmaceutica","status":"publish","type":"post","link":"https:\/\/oytec.es\/ca\/ema-i-fda-els-10-principis-de-la-ia-farmaceutica\/","title":{"rendered":"EMA i FDA: els 10 principis de la IA farmac\u00e8utica"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb2px|||||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb text_font=\u00bbMontserrat||||||||\u00bb header_font=\u00bbMontserrat||||||||\u00bb header_text_align=\u00bbjustify\u00bb header_font_size=\u00bb14px\u00bb text_orientation=\u00bbjustified\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<p>La Uni\u00f3 Europea i els Estats Units han publicat els <strong><em>Principis rectors de les bones pr\u00e0ctiques d\u2019IA en el desenvolupament de f\u00e0rmacs<\/em><\/strong>, el passat 14 de gener de 2026, com a part d\u2019un esfor\u00e7 estrat\u00e8gic per homogene\u00eftzar criteris regulatoris. La iniciativa de treball col\u00b7laboratiu EMA-FDA t\u00e9 la missi\u00f3 de promoure la seguretat i la responsabilitat en l\u2019\u00fas de la Intel\u00b7lig\u00e8ncia Artificial amb l\u2019objectiu d\u2019aprofitar les dades, la digitalitzaci\u00f3 i la IA. <\/p>\n<p>Aquest treball ha estat analitzat i divulgat per <strong>Guillem L\u00f3pez<\/strong>,<strong> CSV &#038; QA Manager <\/strong>de <strong>OYTEC<\/strong>, autor de l\u2019article <a href=\"https:\/\/oytec.es\/wp-content\/uploads\/Los-10-principios-de-la-IA-farmaceutica-segun-la-EMA-y-la-FDA_Guillem-Lopez_OYTEC.pdf\" target=\"_blank\" rel=\"noopener\"><strong>\u00abEls 10 principis de la IA farmac\u00e8utica segons l\u2019EMA i la FDA\u00bb<\/strong><\/a>.<\/p>\n<p>[\/et_pb_text][et_pb_image src=\u00bbhttps:\/\/oytec.es\/wp-content\/uploads\/Picture1-1843&#215;1080.png\u00bb title_text=\u00bbIA-FDA-EMA-graphic\u00bb align=\u00bbcenter\u00bb _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb width=\u00bb45%\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][et_pb_text ol_item_indent=\u00bb40px\u00bb _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb text_font=\u00bbMontserrat||||||||\u00bb ul_font=\u00bbMontserrat||||||||\u00bb ol_font=\u00bbMontserrat|&#8211;et_global_body_font_weight|||||||\u00bb ol_text_align=\u00bbjustify\u00bb ol_line_height=\u00bb2em\u00bb header_2_font=\u00bbMontserrat||||||||\u00bb header_2_text_align=\u00bbjustify\u00bb text_orientation=\u00bbjustified\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2>Marc com\u00fa, execuci\u00f3 diferent<\/h2>\n<p>L\u2019alineaci\u00f3 de criteris entre ambdues ag\u00e8ncies reguladores t\u00e9 l\u2019objectiu de guiar l\u2019\u00fas de la IA en l\u2019\u00e0mbit farmac\u00e8utic sense frenar la innovaci\u00f3. Tanmateix, quan aquests principis es traslladen als esborranys regulatoris, emergeixen matisos rellevants: objectius compartits, per\u00f2 enfocaments diferents. [\/et_pb_text][et_pb_gallery gallery_ids=\u00bb10668,10686&#8243; fullwidth=\u00bbon\u00bb _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb width=\u00bb50%\u00bb max_width=\u00bb100%\u00bb module_alignment=\u00bbcenter\u00bb box_shadow_style=\u00bbpreset2&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_gallery][et_pb_text ol_item_indent=\u00bb40px\u00bb _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb text_font=\u00bbMontserrat||||||||\u00bb ul_font=\u00bbMontserrat||||||||\u00bb ol_font=\u00bbMontserrat|&#8211;et_global_body_font_weight|||||||\u00bb ol_text_align=\u00bbjustify\u00bb ol_line_height=\u00bb2em\u00bb header_2_font=\u00bbMontserrat||||||||\u00bb header_2_text_align=\u00bbjustify\u00bb text_orientation=\u00bbjustified\u00bb global_colors_info=\u00bb{}\u00bb]En les conclusions de l\u2019article, L\u00f3pez destaca que <strong>\u201cL\u2019alineaci\u00f3 reguladora UE\u2013EUA en mat\u00e8ria d\u2019intel\u00b7lig\u00e8ncia artificial ja \u00e9s visible i substancial, amb una visi\u00f3 comuna basada en el risc, el <em>context of use<\/em>, la supervisi\u00f3 humana, la governan\u00e7a de dades i la gesti\u00f3 del cicle de vida.\u201d<\/strong>. No obstant aix\u00f2, observa difer\u00e8ncies: per part de l\u2019EMA s\u2019integra la IA en el marc GMP de manera preventiva i estructurada i la FDA prioritza la credibilitat i la proporcionalitat a l\u2019\u00fas. <\/p>\n<p>Aquests principis s\u2019exposen en el document conjunt de les ag\u00e8ncies <a href=\"https:\/\/oytec.es\/wp-content\/uploads\/guiding-principles-good-ai-practice-drug-development_en.pdf\" target=\"_blank\" rel=\"noopener\"><em>Guiding Principles of Good AI Practice in Drug Development<\/em><\/a>. Aix\u00ed mateix, en <a href=\"https:\/\/www.gmp-compliance.org\/files\/guidemgr\/mp_vol4_chap4_annex22_consultation_guideline_en.pdf\" target=\"_blank\" rel=\"noopener\">l\u2019esborrany de l\u2019Annex 22 de l\u2019EMA<\/a> i en <a href=\"https:\/\/www.fda.gov\/media\/184830\/download\" target=\"_blank\" rel=\"noopener\">la guia marc de credibilitat d\u2019IA de la FDA<\/a>. <\/p>\n<p>&nbsp;[\/et_pb_text][et_pb_text _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb text_font=\u00bbMontserrat||||||||\u00bb header_font=\u00bbMontserrat||||||||\u00bb header_2_font=\u00bbMontserrat||||||||\u00bb header_2_text_align=\u00bbjustify\u00bb text_orientation=\u00bbjustified\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2>Com OYTEC implementa la IA<\/h2>\n<p>OYTEC implementa <strong>solucions d\u2019IA en entorns GxP juntament amb partners tecnol\u00f2gics com Siemens i Aizon<\/strong>, alineant plans i informes de credibilitat i el compliment GMP. Per aprofundir-hi, podeu contactar amb <a href=\"https:\/\/oytec.es\/contacto\/\" target=\"_blank\" rel=\"noopener\">els nostres experts.<\/a> [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb9px|||||\u00bb z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_row module_class=\u00bb et_pb_row_fullwidth\u00bb _builder_version=\u00bb4.16&#8243; width=\u00bb89%\u00bb width_tablet=\u00bb80%\u00bb width_phone=\u00bb\u00bb width_last_edited=\u00bbon|desktop\u00bb max_width=\u00bb89%\u00bb max_width_tablet=\u00bb80%\u00bb max_width_phone=\u00bb\u00bb max_width_last_edited=\u00bbon|desktop\u00bb custom_padding=\u00bb11px|0px|38.0469px|0px|false|false\u00bb z_index_tablet=\u00bb500&#8243; make_fullwidth=\u00bbon\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_divider _builder_version=\u00bb4.16&#8243; z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_divider][et_pb_text _builder_version=\u00bb4.16&#8243; text_font=\u00bbRoboto||||||||\u00bb text_text_color=\u00bb#000000&#8243; z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb]<strong style=\"color: #333333; font-size: 22px;\">\u00daltimes not\u00edcies<\/strong>[\/et_pb_text][et_pb_blog fullwidth=\u00bboff\u00bb posts_number=\u00bb3&#8243; include_categories=\u00bb3,5,17,7&#8243; show_more=\u00bbon\u00bb show_date=\u00bboff\u00bb _builder_version=\u00bb4.16&#8243; z_index_tablet=\u00bb500&#8243; box_shadow_style=\u00bbpreset3&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_blog][et_pb_button button_url=\u00bbhttps:\/\/oytec.es\/blog-oytec\/\u00bb button_text=\u00bbM\u00e9s not\u00edcies\u00bb button_alignment=\u00bbcenter\u00bb _builder_version=\u00bb4.16&#8243; z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; _module_preset=\u00bbdefault\u00bb background_color=\u00bb#eef1f7&#8243; background_image=\u00bbhttps:\/\/www.oytec.es\/wp-content\/uploads\/2021\/03\/Footer_Oytec_400.jpg\u00bb background_enable_image=\u00bboff\u00bb custom_margin=\u00bb||-55px|||\u00bb custom_padding=\u00bb3px||3px|||\u00bb saved_tabs=\u00bball\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_5,1_5,1_5,1_5,1_5&#8243; _builder_version=\u00bb4.16&#8243; _module_preset=\u00bbdefault\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.16&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb-9px||20px||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<strong>BARCELONA<\/strong>[\/et_pb_text][et_pb_text admin_label=\u00bbTexto\u00bb _builder_version=\u00bb4.16&#8243; text_font=\u00bbRoboto||||||||\u00bb text_text_color=\u00bb#636363&#8243; header_3_font=\u00bb|||on|||||\u00bb header_6_text_color=\u00bb#7c7c7c\u00bb background_layout=\u00bbdark\u00bb custom_padding=\u00bb0px|||||\u00bb z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb]<\/p>\n<aside>@SANTCUGAT building<\/aside>\n<aside>Av. 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La iniciativa de treball col\u00b7laboratiu EMA-FDA t\u00e9 la missi\u00f3 de promoure la seguretat i la responsabilitat [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":11075,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[224,231,232,227],"tags":[233,249,234,235,252,236],"class_list":["post-11071","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized-ca","category-gmp-2","category-ia-2","category-transformacio-digital","tag-2026-2","tag-ai-2","tag-divulgacio","tag-ema-2","tag-fda-2","tag-gmp-2"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EMA i FDA: els 10 principis de la IA farmac\u00e8utica - 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