Asphalion attended the 14th EGA Regulatory and Scientific Affairs Conference (London 22 – 23/01/15)
Our Regulatory Information Director, Remco Munnik, spoke at 2 sessions.
Asphalion supported the 2014 TV3 Telethon
The 23rd edition of La Marató de TV3 was broadcasted on 14 December and focused on heart disease, one of the main causes of death worldwide and in Catalonia.
Webinar gratuito: Cómo preparar y superar una Inspección de Farmacovigilancia
Acceda al webinar sobre Farmacovigilancia que ASPHALION y EXTEDO ofrecieron el pasado mes de noviembre.
Asphalion supports the Tsemai tribe school in Keerkale, Ethiopia
Two of our team members visited the school and delivered the supplies.
First photo contest of Asphalion’s employees
These are the most outstanding photos from the contest.
Lidia Cánovas and our US Agent speakers at the Ready4Growth seminar
Ready4Growth took place on November 24 in Barcelona.
Asphanews November 2014
Read about the latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.
EMA publishes final version of Biosimilar guideline
On 29 October 2014, EMA presented the final version of their guideline on biosimilars. This document replaces the previous guidance document of 2005, provides several clarifications and introduces one important change intended to ease global development of biosimilars.
Asphalion attended CPhI (7 – 9/10 in Paris, FR)
CPHi is one of the most important events in the Pharmaceutical Industry, mainly focused on pharma market news and trends on a global scale.
Asphalion attended BIOSPAIN 2014 (24 – 26/09, Santiago de Compostela)
Our team also attended Xacobio, a three-day walk before Biospain on the Camino de Santiago.
AEMPS: improvements in fee payment system
As from 1 October the AEMPS, will have a new bank payments gateway available so as to increase payment security and facilitate procedures.
European Comission: Notice to applicants, update of variations and renewal application forms (human and veterinary)
The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.
Asphalion attended AEFI 2014 (04 – 05/06 – Madrid, Spain)
During the Symposium we taught 2 workshops.
Asphalion attended ECRD 2014 (08 – 10/05, Berlin)
Lidia Canovas, and our US Agent, Bruce Thompson were at the European Conference on Rare Diseases and Orphan Products.
AsphaNews 5: May 2014
The latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.
Complimentary Webinar: Get Ready for the 2014 xEVMPD Requirements (3rd April 2014)
Use EXTEDO’s free-of charge solution MPDviewer
Asphalion attended DIA’s 26th Annual EuroMeeting in Vienna (25-27 March 2014)
Over the years, this conference has become a real centre of attention for regulatory professionals and related life science experts.
Complimentary Webinar: Get Ready for the 2014 xEVMPD Requirements
Use Extedo’s free-of charge solution MPDviewer
FDA GDUFA Performance Report
FDA published the Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report
New requirements in Spain for presentation of SmPC and PIL
This new procedure is now also mandatory for any kind of variation that modifies these documents.
AsphaNews 4: January 2014
The latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.
Asphalion is a proud member of the iHivarna consortium
The four-year 6M Euro project, funded by the European Commission, aims to successfully immunize antiretroviral-treated HIV-infected patients.
Highlights of the New Real Decreto RD 577/2013 on Pharmacovigilance
The New Real Decreto RD 577/2013 on Pharmacovigilance was published on 27th July 2013.
AsphaNews 3: October 2013
We are excited to present the new issue of our newsletter: ASPHAnews
Asphalion at BIO-Europe 2013
Meet several consultants of ASPHALION at the 19th annual BIO-Europe conference in Vienna.
