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.
Fighting diabetes: TERMIS EU 2019 in Rhodes
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.
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.
