{"id":6750,"date":"2014-05-11T09:50:06","date_gmt":"2014-05-11T09:50:06","guid":{"rendered":"http:\/\/www.cefi.es\/?post_type=product&p=6750"},"modified":"2020-02-11T12:15:39","modified_gmt":"2020-02-11T12:15:39","slug":"seminario-vision-juridica-medicamentos-biosimilares","status":"publish","type":"product","link":"https:\/\/cefi.es\/en\/tienda\/cursos-y-seminarios\/seminarios\/seminarios-sector-farmaceutico-industria-farmaceutica\/seminario-vision-juridica-medicamentos-biosimilares\/","title":{"rendered":"Seminario Visi\u00f3n Jur\u00eddica Medicamentos Biosimilares"},"content":{"rendered":"\n\n\n\n\n\n\n\n\n\n
8:45 – 9:15<\/strong><\/td>\n\n
Recepcio\u0301n de asistentes y entrega de documentacio\u0301n<\/h5>\n<\/td>\n<\/tr>\n
9:15 – 9:30<\/strong><\/td>\n\n
Apertura<\/h5>\n

Maria Alonso Burgaz. Presidenta Fundacio\u0301n CEFI <\/strong>
\nRegina Revilla Pedreira. Presidenta ASEBIO<\/strong><\/td>\n<\/tr>\n

9:30 – 10:15<\/strong><\/td>\n\n
Concepto medicamento biolo\u0301gico\/medicamento biosimilar. Aspectos conceptuales. Aspectos me\u0301dicos, de fabricacio\u0301n y econo\u0301micos<\/h5>\n

Jose\u0301 Luis Motello\u0301n Garci\u0301a. Director Me\u0301dico AMGEN<\/td>\n<\/tr>\n

10:15 – 11:00<\/strong><\/td>\n\n
Marco normativo actual. Prescripcio\u0301n y dispensacio\u0301n de biosimilares<\/h5>\n

Prescripcio\u0301n por denominacio\u0301n comercial para biolo\u0301gicos. Cambio en el Real Decreto de receta me\u0301dica para prescripcio\u0301n de biolo\u0301gicos por marca<\/strong><\/p>\n

No sustitucio\u0301n de biosimilares. 86.4 Ley 29\/2006 (modificada en 2013). Re\u0301gimen especi\u0301fico. Orden Ministerial 2007 de medicamentos no sustituibles. Responsabilidad civil del prescriptor y dispensador en caso de sustitucio\u0301n o intercambio<\/strong><\/p>\n

Jose Miguel Fata\u0301s. Abogado Uri\u0301a Mene\u0301ndez<\/td>\n<\/tr>\n

11:00 – 11:30<\/strong><\/td>\n\n
Pausa cafe\u0301<\/h5>\n<\/td>\n<\/tr>\n
11:30 – 13:00<\/strong><\/td>\n\n
Mesa redonda \u00bfNecesidad de una regulacio\u0301n especi\u0301fica biolo\u0301gicos\/biosimilares por sus caracteri\u0301sticas?<\/h5>\n

\u00bfCo\u0301mo deberi\u0301a ser esta regulacio\u0301n? Prescripcio\u0301n por marca, no sustitucio\u0301n, re\u0301gimen de precios ( exclusio\u0301n de precios de referencia; lotes independientes). Aspectos juri\u0301dicos importantes a tener en cuenta<\/strong><\/p>\n

Anticuerpos monoclonales: \u00bfuna categori\u0301a diferente y una regulacio\u0301n ad-hoc dentro de los fa\u0301rmacos biolo\u0301gicos?<\/strong><\/p>\n

Aproximacio\u0301n a la regulacio\u0301n de la sustitucio\u0301n e intercambiabilidad en otros pai\u0301ses: Francia, Canada\u0301, UK<\/strong><\/p>\n

Ramo\u0301n Sa\u0301nchez Diaz-Caldero\u0301n. Director Productos Biolo\u0301gicos. Roche<\/p>\n

Participan en el debate:<\/strong>
\nDr. Fernando Carballo. Presidente y Vocal Comite\u0301 Excelencia Cli\u0301nica. Sociedad Espan\u0303ola Patologi\u0301a Digestiva (SEPD). Profesor Titular de Medicina Universidad de Murcia. Jefe Servicio Medicina Aparato Digestivo y Director Unidad Gestio\u0301n Cli\u0301nica Digestivo Hospital Cli\u0301nico Universitario Virgen de Arrixaca
\nIrene Andre\u0301s Justi. Directora Legal MSD
\nJordi Faus Santasusana. Abogado socio Faus & Moliner<\/td>\n<\/tr>\n

13:00 – 13:45<\/strong><\/td>\n\n
Trazabilidad y farmacovigilancia. Ejemplos de Europa y EMA. Planes de gestio\u0301n de riesgos y de farmacovigilancia especi\u0301ficos<\/h5>\n

Dra. Arantxa Sancho. Miembro del CHMP. Me\u0301dico especialista en Farmacologi\u0301a Cli\u0301nica del Instituto de Investigacio\u0301n Sanitaria Puerta de Hierro<\/td>\n<\/tr>\n

14:00<\/strong><\/td>\n\n
Clausura<\/h5>\n

Agusti\u0301n Rivero Cuadrado. Director General Cartera Ba\u0301sica de Servicios SNS y Farmacia<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Seminario Visi\u00f3n Jur\u00eddica Medicamentos Biosimilares.<\/p>\n","protected":false},"featured_media":5815,"template":"","meta":{"_acf_changed":false},"product_brand":[],"product_cat":[78,94],"product_tag":[],"class_list":{"0":"post-6750","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-seminarios","7":"product_cat-seminarios-sector-farmaceutico-industria-farmaceutica","9":"first","10":"outofstock","11":"virtual","12":"taxable","13":"purchasable","14":"product-type-simple"},"acf":[],"yoast_head":"\nSeminario Visi\u00f3n Jur\u00eddica Medicamentos Biosimilares - Centro de estudios para el fomento de la investigaci\u00f3n<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cefi.es\/en\/tienda\/cursos-y-seminarios\/seminarios\/seminarios-sector-farmaceutico-industria-farmaceutica\/seminario-vision-juridica-medicamentos-biosimilares\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Seminario Visi\u00f3n Jur\u00eddica Medicamentos Biosimilares - 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