Following with 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.
The transition from siloed systems to a unified regulatory information management (RIM) platform that fully supports end-to-end business processes is underway.
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.
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?
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?
The COVID-19 pandemic is causing major disruptions that impact citizens, patients and businesses, including the activities of pharmaceutical companies.
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.
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.
Data data data…
It seems that this new decade will become the decade of data.
Even though there is a fair amount of turmoil regarding Brexit, MHRA is getting ready for a worst-case scenario, a no-deal Brexit.
Telematics strategy of the different Regulatory Authorities is having an increasing growth.
Today we’re going to talk about the main e-submission portals.
16 countries, 36 among universities, SMEs and research institutions across Europe, Israel and the United States are the protagonists of the EU-H2020 funded research that is being presented today at the European Chapter Meeting 2019 of the Tissue Engineering and Regenerative Medicine International Society (TERMIS). Novel therapeutic strategies and the latest advances in insulin-producing cell transplantation technologies will be discussed.
Following with our program Asphalion – partners hacía el futuro we offer you a new webinar on “eSUBmanager: share sequences, save time and space”.
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.