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 ...
Read moreThe European Medicines Agency Network Strategy to 2025 was detailed just last week during the 20th Regulatory Affairs and Pharmacovigilance conference.
Read moreTras 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...
Read moreLa 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...
Read moreToday, 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 ...
Read moreOne 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.
Read moreLast week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure”.
Read moreSartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has announced the launch of its new Sartocheck® 5 Plus filter integrity tester.
Read moreThe 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...
Read moreHoy, 20 de mayo, se celebra en todo el mundo el Día Internacional del Ensayo Clínico
Read moreLa 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...
Read moreIn 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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