This year, the meeting will be taking place from 14-15 March 2019 at the Hotel Sants Barceló, Barcelona. We are delighted and proud to announce that Asphalion experts will actively participate in the conference.
FDA updated the guideline for Providing Regulatory Submissions in Electronic Format to reflect that the requirement for Type III drug master files (DMFs) to be filed electronically takes place 60 months after May 5, 2015.
Currently, validation issues occur in 90% of initial marketing authorisation applications (MAAs). These validation issues create additional workload for companies and potential delays at a critical moment for the timely start of the procedure.
There is few time left until end of March and there are still quite some uncertainties with regards to the Brexit.
Asphalion can assist with the RMS transfer and provide EU QPPV, PSMF establishment and SME registration within the EU.
Next 24/02, Asphalion joins the solidarity march for the Hospital Sant Joan de Déu: La Magic Line. Our team AsphaLion will walk 20 km to help the most vulnerable people in #Barcelona!
Núria Romero Carol and Sonia López Sánchez in the workshop “Innovation and Digital Transformation in Pharma & Medical Device Vigilance: Regulatory and Technology Update”
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!