(Cas) AEMPS: Las XV Jornadas de Inspección Farmacéutica impulsan la colaboración entre las administraciones sanitarias en un momento marcado por la pandemia de COVID-19
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Bajo el lema “Inspección en tiempos de pandemia”, el Comité Técnico de Inspección impulsa la sinergia y la coordinación entre administraciones [...]
(Cas) La AEMPS crea una sección sobre etiquetado de medicamentos con información útil para profesionales, industria y ciudadanía
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Este apartado compila todas las recomendaciones relevantes relacionadas con el diseño e información a incluir en el etiquetado, de acuerdo a [...]
(Cas) AEMPS: Recomendaciones de la EMA sobre terceras dosis y dosis de refuerzo de las vacunas frente a la COVID-19 Comirnaty y Spikevax
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La agencia europea indica que podrían administrarse terceras dosis de las vacunas Comirnaty (BioNTech/Pfizer) y Spikevax (Moderna) a personas trasplantadas e [...]
(Cas) AEMPS: La AEMPS publica la traducción al español de la guía para los fabricantes de productos sanitarios de clase I
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La traducción del documento “MDCG 2019-15 rev.1 – Guía para los fabricantes de productos sanitarios clase I” tiene como fin ayudar [...]
(Cas) La AEMPS, STANPA y expertos de la industria cosmética elaboran una guía para producir materias primas y productos cosméticos microbiológicamente seguros
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Esta guía está destinada a formuladores, microbiólogos y a la industria cosmética en general, y ofrece pautas para conseguir productos cosméticos [...]
EMA: COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
Authorities in the EU are aware that a batch of the active substance for COVID-19 Vaccine Janssen had been contaminated with materials for another vaccine manufactured at the same site. The contamination occurred at a manufacturing site for the active substance in Maryland, United States, owned by Emergent Biosolutions. The batch concerned was not intended for the EU market. [...]
(Cas) La AEMPS lanza la aplicación CNCps para la certificación telemática de productos sanitarios y de sistemas de gestión de calidad
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Esta herramienta hace posible un desarrollo totalmente electrónico de los trámites de certificación de marcado CE y de la norma UNE [...]
Infarmed: Medicamentos para uso humano que contêm as substâncias ativas “candesartan”, “irbesartan”, “losartan”, “olmesartan” e “valsartan”: implementação nacional da Decisão C(2021) 1309, de 19/02/2021
Na sequência do procedimento de arbitragem artigo 31.º para os medicamentos para uso humano que contêm as substâncias ativas «candesartan», «irbesartan», «losartan», olmesartan», «valsartan» foi adotada a Decisão da Comissão Europeia C(2021) 1309 de 19/02/2021, que determina a alteração dos termos da Autorização de Introdução no Mercado dos medicamentos em causa. Em linha com as recomendações [...]
FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products
The following quote is attributed to Michael Kopcha Ph.D., R.Ph., director of the FDA’s Office of Pharmaceutical Quality “The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonization of requirements for drug [...]
FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward. “Like most organizations around the [...]
FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
The U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness. As part of our regulatory processes for reviewing all [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
EMA: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. New manufacturing site for AstraZeneca’s COVID-19 vaccine A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring [...]
FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients
Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients. “Today’s [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]