La Agencia Europea del Medicamento inicia el proceso para autorizar la vacuna rusa Sputnik V

by Agencia Sinc

El organismo europeo encargado de la aprobación de fármacos ha iniciado una ‘revisión continua’ de Sputnik V, la vacuna contra la covid-19 desarrollada por el Centro Nacional de Epidemiología ...

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EMA Network strategy to 2025

by Asphalion

The European Medicines Agency Network Strategy to 2025 was detailed just last week during the 20th Regulatory Affairs and Pharmacovigilance conference.

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La Comisión Europea autoriza el uso de la vacuna de Moderna

by Agencia Sinc

Tras el visto bueno de su Agencia de Medicamentos, la Unión Europea ha aprobado la comercialización de la vacuna de Moderna, que proporcionará 160 millones de dosis hasta el tercer trimestre de 202...

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Sermes CRO: Novedades sobre el nuevo portal europeo de ensayos clínicos de la EMA (CTIs)

by Sermes CRO

​La Agencia Europea de Medicamentos (EMA) tiene como objetivo tener listo su sistema de información de ensayos clínicos (CTIS) en diciembre de 2021, comprometiéndose con este objetivo en la actua...

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Workshop on support for orphan medicines development by EMA

by Asphalion

Today, Montse de Castellarnau, Scientific & Regulatory Affairs Officer at Asphalion, will be attending the “Workshop on support for orphan medicines development”. The workshop is organized by the ...

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Is your xEVMPD database ready?

by Asphalion

One of the first steps executed by the EMA to prepare for the implementation of ISO IDMP will be the migration into the new PMS database.

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Updated version of the document 'EMA post-authorisation procedural advice for users of the centralised procedure'

by Asphalion

Last week, European Medicin​es Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised proc​edure”.

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Sartorius Stedim Biotech launches new Sartocheck® 5 Plus Filter Tester

by Sartorius Stedim Spain

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has announced the launch of its new Sartocheck® 5 Plus filter integrity tester.

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Drug Device Combinations: Consultation on draft guideline on quality requirements

by Asphalion

​The European Medicines Agency (EMA) released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD (known as drug device combinations or DDC) f...

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La Metformina, designada medicamento huérfano para la enfermedad de Lafora en Estados Unidos

by CIBERER - Centro de Investigación Biomédica en Red de Enfermedades Raras

La Food and Drug Administration (FDA) de Estados Unidos ha designado la Metformina como medicamento huérfano para el tratamiento de la enfermedad de Lafora, un trastorno neurodegenerativo poco frecue...

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Pharmacovigilance: EMA proposed changes to preparation of risk management plans

by Azierta

In early 2016, the European Medicines Agency (EMA) started a major revision process of the good pharmacovigilance practice (GVP) Module V on risk management systems. Consequent to this, the Agency sha...

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