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COVID-19: AEMPS to carry out remote inspections of Good Practice in PV

The AEMPS announced last week that in order to allow the normal activity of MAHs and to be able to supervise it adequately, the GCP and GMP inspection area will carry out remote pharmacovigilance inspections whenever possible.

The AEMPS announced last week that in order to allow the normal activity of MAHs and to be able to supervise it adequately, the GCP and GMP inspection area will carry out remote pharmacovigilance inspections whenever possible.
June 4, 2020

Due to the current situation originated by COVID-19, the Spanish Agency for Medicines and Health Products (AEMPS) announced last week that in order to allow the normal activity of Marketing Authorisation Holders (MAHs) and to be able to supervise it adequately, the Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GMP) inspection area will carry out remote pharmacovigilance inspections whenever possible, including it within the risk-based inspection plan, in place since 2016.

Therefore, the AEMPS recommends MAHs to update their remote video communication systems, document exchange platforms, and check access to their own systems as well as those of third parties related to any pharmacovigilance activity.

The GCP and GMP inspection department will communicate with the contact person for Pharmacovigilance/QPPV of the MAHs to be audited in order to evaluate if remote inspection is possible. Once evaluated, the inspection will be announced through the LABOFAR inspection management system. From there, the communication between the auditing and audited teams will be carried out in the usual way.

At Asphalion we have an expert team in PV audits and we carry out both audits of the client’s PV system and subsidiaries, distributors, service companies, etc. We are experts in both on premises and remote audits, due to that we know which are the challenges to be faced during remote audits. In the audits we adapt to customer requirements and current regulations. The audits have a training-type character with the focus of helping clients to improve their PV system. Apart from detecting the findings and classifying them according to their criticism, these findings are reviewed and accompanied by recommendations on how to solve them.

If you need any help, do not hesitate to contact us at info@asphalion.com

 


 

COVID-19 | La AEMPS realizará inspecciones de Buena Práctica de Farmacovigilancia en remoto

La semana pasada la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informó que, debido a la crisis sanitaria causada por el COVID-19 y para permitir la actividad normal de los Titulares de Autorización de Comercialización (TAC) y poder supervisarla adecuadamente, el Área de inspección de Buena Práctica Clínica (BPC) y Buena Práctica de Farmacovigilancia (BPFV) comenzará a realizar inspecciones remotas de farmacovigilancia siempre que sea posible, incluyéndolo dentro del plan de inspección basado en riesgo, en marcha desde 2016.

Para ello, la AEMPS recomienda a los TAC la actualización de sus sistemas electrónicos de video comunicación remota, plataformas de intercambio de documentos, y la comprobación de los accesos tanto a los sistemas propios como a los de terceras partes relacionadas con cualquier actividad relacionada con farmacovigilancia.

El Área de inspección de BPC y BPFV se comunicará con la persona de contacto para Farmacovigilancia/QPPV de los TAC que vayan a ser inspeccionados para poder valorar si es posible efectuarla en remoto. Una vez evaluado, se procederá a anunciar la inspección a través del sistema de gestión de inspecciones LABOFAR. A partir de allí, la comunicación entre el inspeccionado y el equipo inspector se hará de la forma habitual.

En Asphalion contamos con un personal experto en auditorías de FV y realizamos tanto auditorías al sistema de FV del cliente como a las filiales, distribuidores, compañías de servicios, etc. A lo largo de nuestra experiencia, hemos realizado auditorías tanto presenciales como en remoto, por lo que sabemos los retos que se pueden presentar durante una auditoría en remoto. En las auditorías nos adaptamos a los requisitos del cliente y a las normativas vigentes. Las auditorías tienen un carácter formativo con el objetivo de ayudar al cliente a mejorar su sistema de FV. A parte de detectar los hallazgos y clasificarlos según su criticidad, estos hallazgos son argumentados y acompañados de recomendaciones de cómo subsanarlos.

Si necesitas alguna ayuda, no dejes de contactar con nosotros: info@asphalion.com

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