News and Events
Stay in touch with the latest news and upcoming events featuring Asphalion
NEWS | QWP Questions and Answers: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)
This document aims to clarify existing guidance as a compilation of required data to be submitted in a MAA or in certain MAVs when a CEP is referred to in the MA dossier. It is also applicable when an excipient covered by a CEP is used as an active substance (AS). Even if several aspects of this document would equally apply to ASMFs and when full information on active substance is provided in the MA dossier, the focus of this Q&A is on CEPs.
NEWS | QWP Questions and Answers: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)
This document aims to clarify existing guidance as a compilation of required data to be submitted in a MAA or in certain MAVs when a CEP is referred to in the MA dossier. It is also applicable when an excipient covered by a CEP is used as an active substance (AS). Even if several aspects of this document would equally apply to ASMFs and when full information on active substance is provided in the MA dossier, the focus of this Q&A is on CEPs.
More News & Events
HORIZON | ETERNAL 18-month progress meeting
The EU-funded project ETERNAL partners gathered in Rome this week to discuss the ongoing progress of the
EVENT | Nit CataloniaBio & HealthTech 2024
This week Asphalion experts Lidia Cánovas, Oriol Penon, Marta Rayo Lunar, Talyta Carteano and Fran Rodríguez attended
CardioReGenix project | March 2024 Progress meeting
The EU-funded CardioReGenix project focuses on technological innovations for the treatment of heart failure and myocardial ischemia. The goal is to overcome obstacles in cardiovascular disease (CVD) gene therapy, capitalising on robust preliminary data and multi-disciplinary consortium know-how in vector development, preclinical and clinical cardiology, business development and clinical translation.
WEBINAR RECORDING | From Theory to Reality: What are the challenges & opportunities of setting up your Post-Marketing Surveillance System
Watch Asphalion expert Laura Eder diving into the opportunities that will bring you building up your Post-Marketing
Awareness | International Women´s Day 2024
International Women’s Day is a global day to celebrate social, economic, cultural and political achievements of women.
Novedades Regulatorias | Medicamentos a base de Alérgenos de uso humano
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha delineado el marco regulatorio y las responsabilidades
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