Yesterday, our experts Lidia Cánovas and Oriol Penon gave two training sessions at CIC bioGUNE on ‘Regulatory Introduction for medical devices’ and ‘Regulatory Introduction for medicinal products’, respectively.
We are excited to announce that Remco Munnik, our Regulatory Information Director, will be speaking in the DIA’s Regulatory Submissions, Information and Document Management Forum (USA).
During the lapse period, the agency will be continuing only vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States.
If you are interested in starting the year by getting fully informed about the activities and future plans in Regulatory in Europe, Medicines for Europe´s conference is the best place.
In January 2019, the revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ will enter into force.
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