The European Union has awarded a grant of 25.5€ million for the Accelerating Research and Innovation for Advanced Therapies (ARDAT) project.
New H2020 project | Asphalion is participating in the VASCOVID project
Asphalion is the regulatory partner for a successfully funded Horizon 2020 project entitled VASCOVID, one of the new research projects selected to receive EU funding for research against COVID-19.
Batch Testing and Release: LIFE AFTER BREXIT
We at KYMOS and ASPHALION are long-time partners in providing analytical and regulatory services to international pharma and biotech sectors.
BREXIT | Pharmacovigilance system requirements from 1 January 2021
Following the news and updates from the MHRA and to ensure that all the involved parties can prepare for the new scenario, the Agency has published a guidance on QPPV including PSMF from 1 January 2021.
WHITE PAPER | 3 Success Criteria for a Unified Regulatory Solution
The transition from siloed systems to a unified regulatory information management (RIM) platform that fully supports end-to-end business processes is underway.
Regulation of medical devices after Brexit: what’s new?
With the end of the year around the corner, the transition period after Brexit is about to come to an end. From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the United Kingdom’s standalone medicines and medical devices regulator.
IDMP and RIMS, what we have learned with this situation
Being forced into teleworking has made us realized about lot of things. Things we can improve and ways of working we should change. But, what should we change? Is there any way to improve?
IDMP y RIMS, lo que hemos aprendido de esta situación
Vernos forzados a realizar teletrabajo ha hecho que nos demos cuenta de muchas cosas. Cosas que podemos mejorar y formas de trabajo que deberíamos cambiar. Pero ¿qué es eso que tenemos que cambiar? ¿Hay alguna forma de mejorar?
New guidance on regulatory requirements during COVID-19 pandemic
The COVID-19 pandemic is causing major disruptions that impact citizens, patients and businesses, including the activities of pharmaceutical companies.
AsphaTrainings Program | At Asphalion we preparing a spring full of online trainings in Regulatory Affairs
We are very pleased to announce the launch of the AsphaTrainings Program. We think it is essential to keep our Regulatory Affairs community updated and trained during this time. As a response to the postponement of most educational events in the field of Regulatory Affairs due to COVID-19, our aim is to offer high quality RA Content.
Novel Regeneration Techniques for Large Bone Defects: Launch of EU Research Project SBR
The ten academic and industrial partners collaborating in the new EU research project SBR (Smart Bone Regeneration) aim to improve treatment options for patients with large bone defects.
Big Data for public health in the EU: HMA-EMA’s recommendations
Data data data…
It seems that this new decade will become the decade of data.
Regulating medical devices in the event of a no-deal Brexit
Even though there is a fair amount of turmoil regarding Brexit, MHRA is getting ready for a worst-case scenario, a no-deal Brexit.
eSubmission Portals
Telematics strategy of the different Regulatory Authorities is having an increasing growth.
Today we’re going to talk about the main e-submission portals.
Asphalion Webinar on eSUBmanager: share sequences, save time and space
Following with our program Asphalion – partners hacía el futuro we offer you a new webinar on “eSUBmanager: share sequences, save time and space”.
Atlas Molecular Pharma receives an ODD with Asphalion support
On January 17th, 2018, the European Commission granted Ciclopirox (L2.7.D7) the Orphan Drug Designation (ODD) and few months later, on 17th April 2018, the Food and Drug Administration (FDA) also granted ODD for the product. This is the first time that the agencies issue a positive opinion for this rare disease. Therefore, Ciclopirox represents the only drug with ODD for this genetic condition. Asphalion and Atlas have been working together in this challenging process for ODD application.
