Atlas Molecular Pharma, a company specialized in the discovery and development of first-in-class, innovative therapeutics for the treatment of Rare and ultra-Rare Diseases, announced that its candidate drug Ciclopirox (L2.7.D7) was granted the ODD status on January 17th 2018 by the European Commision and on 17th April 2018 by the FDA.
Yes, you can ask: “What is the relationship between Henri de Toulousse-Lautrec and Asphalion?” or “Is Asphalion changing its core business to Regulatory Affairs from Art Consultancy?”
El evento tuvo lugar en Barcelona y Madrid, y contó con más de 100 participantes de 50 empresas distintas, todas ellas con sede en España. ¡Gracias a todos por vuestra participación!
Unique Device Identification (UDI) is a new requirement set out in Article 27 and Article 24 (Unique Device Identification system) of both the new Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro diagnostic Device Regulation (EU) 2017/746 (IVDR), respectively.
In order to access this portal it is necessary to have an active EMA account as well as having the affected organisation currently registered in OMS (Organisation Management System).
See you at Biospain 2018 in Sevilla next week! Chat with our regulatory experts Lidia Cánovas, Marta Rayo Lunar, Elisenda Gendra Molina PhD MSc, Oriol Penon and Marina Passarell Rubio and have a free coffee or a healthy juice with them! #Quality #Passion #WeAreAsphalion
MYOCURE is a H2020 project that aims at developing new therapeutic products based on gene therapy for patients suffering from rare inherited muscle diseases
nTRACK is a H2020 project that aims at multimodal nanoparticles for structural and functional tracking of stem cell therapy on muscle regeneration