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  2. Category "Regulación"
Oct292019

VIII AECIC SUMMIT: EU 536/2014 CLINICAL TRIAL REGULATION

VIII AECIC SUMMIT: EU 536/2014 CLINICAL TRIAL REGULATION AECIC (Asociación Española de Compañías de Investigación Clínica/Spanish association of CROs) is aware of the continuous development and innovation in clinical research. Thus, it is necessary to include improvements and…

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Jul82019

Call for all sponsors to publish clinical trial results in EU database

Call for all sponsors to publish clinical trial results in EU database The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of…

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Sep132018

Comunicación de Reacciones Adversas a Medicamentos a eudravigilance.

Comunicación de Reacciones Adversas a Medicamentos a eudravigilance. Desde el pasado día 22 de noviembre de 2017 está disponible la nueva versión de EudraVigilance y comenzó un nuevo flujo de envío de sospechas de reacciones adversas a medicamentos…

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Jun272018

La protección de datos – Nueva regulación adaptada a la era digital

La protección de datos – Nueva regulación adaptada a la era digital El Reglamento General de Protección de Datos (RGPD), que regula el tratamiento que realizan las personas, empresas u organizaciones de los datos personales relacionados con personas…

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Oct252016

Este mes hablamos de… “Experiencia con el nuevo Real Decreto de Ensayos Clínicos en España”.

Los procesos excesivamente complejos y burocratizados, y la fragmentación de las autorizaciones entre las distintas autoridades a nivel europeo e interno son los principales óbices que intenta solventar el Reglamento 536/2014 del Parlamento Europeo y del Consejo, de…

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Sep262016

Este mes hablamos de… “Nuevos Reglamentos Europeos de Productos Sanitarios”

Estimados amigos, La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha celebrado el pasado 13 de septiembre una jornada informativa sobre los Nuevos Reglamentos Europeos de Productos Sanitarios que buscan reforzar las garantías sanitarias en productos de…

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