Don’t forget! On 16th May, Asphalion and Dora Wirth Languages will hold a free webinar to guide you through the process of the Centralised Procedure (CP).
Our team provide comprehensive support during development, validation, certification and manufacturing of Medical Devices (MD) in Europe and the United States.
Last week, our experts Vicente Tur and Oriol Penon participated in the ISGlobal & CRG Career Charla, a series of events co-organized by Centre for Genomic Regulation and ISGlobal aiming to inform pre- and postdoctoral researchers about the career options and possibilities inside and outside of academia.
The Asphalion Open Doors is an unique event organized by Asphalion in collaboration with its partners. This event is free and will provide a structured introduction to all important aspects of Scientific & Regulatory Affairs world.
In the lead up to the imminent FDA opinion on the biologics license application (BLA) for Novartis’ gene therapy Zolgensma for the treatment of spinal muscular atrophy (SMA), the financial media company and magazine Forbes has published an interesting editorial on the controversial issues surround the pricing and reimbursement for ATMPs.
On the eSubmission website a Q&A document has been published on how to handle eCTD for Active Substance Master Files (ASMFs). Asphalion is supporting a large number of ASMF submissions. If you are interested in support, please contact us at: [email protected]
Saint Jordi’s Day is one of the most original celebrations in Catalonia and takes place on 23 April. This popular festival combines culture and romanticism. On this day, it is custom for couples to exchange gifts…
Next week, our Scientific & Regulatory Affairs Associate Director Christopher Mann will be participating in the Invasive Therapies Meeting organised by European Huntington’s Disease Network (EHDN) Invasive Therapies Working Group, in collaboration with SCHD (Stem cells for HD).
On 5 April, Theresa May asked EU for Brexit extension and on 11 April, the EU agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 October 2019.
Asphalion participated in the 3rd Annual Meeting of the H2020 project MYOCURE, the 28th and 29th of March at the Ruprecht-Karls-Universität, in Heidelberg, Germany.
Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited by Eurocat to give a talk on “Aspectos regulatorios en el desarrollo de productos sanitarios”.
In order to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU (Brexit), EMA has published a questions-and-answers document for patients, healthcare professionals and the general public.
The EU has awarded a grant of 15€ million for a research programme to support new gene therapy approaches for the treatment of heart disease. This 5-year project is being coordinated by Professor Marinee Chuah from the Free University of Brussels and includes 13 partners including Asphalion.
Last week, Dominique Monferrer,Scientific & Regulatory Affairs Associate Director at Asphalion, led a very successful Regulatory Training Session on Sanitary Products at AQuAS – Salut.
We are delighted and proud to announce that Asphalion signed a reselling partnership agreement with Agatha Inc., a global leading provider of Quality and Content Management cloud service.
Asphalion, partners hacia el futuro es un programa gratuito dirigido a los departamentos de IT donde nuestros expertos comparten conocimiento y aportan soluciones a los retos diarios.
From 4 to 8 March, the Agency is operating remotely. From 11 to 15 March, EMA staff will gradually move into a temporary building in Amsterdam, called the Spark building.
We are proud to announce the opening of our new office in Amsterdam.
Our new offices are located next to the future location of the European Medicines Agency (EMA), at the World Trade Center.
This year, the meeting will be taking place from 14-15 March 2019 at the Hotel Sants Barceló, Barcelona. We are delighted and proud to announce that Asphalion experts will actively participate in the conference.
FDA updated the guideline for Providing Regulatory Submissions in Electronic Format to reflect that the requirement for Type III drug master files (DMFs) to be filed electronically takes place 60 months after May 5, 2015.
Currently, validation issues occur in 90% of initial marketing authorisation applications (MAAs). These validation issues create additional workload for companies and potential delays at a critical moment for the timely start of the procedure.
There is few time left until end of March and there are still quite some uncertainties with regards to the Brexit.
Asphalion can assist with the RMS transfer and provide EU QPPV, PSMF establishment and SME registration within the EU.
Next 24/02, Asphalion joins the solidarity march for the Hospital Sant Joan de Déu: La Magic Line. Our team AsphaLion will walk 20 km to help the most vulnerable people in #Barcelona!
Núria Romero Carol and Sonia López Sánchez in the workshop “Innovation and Digital Transformation in Pharma & Medical Device Vigilance: Regulatory and Technology Update”