Asphalion organized the 2nd Scientific Advice meeting for the iHIVARNA project.
The meeting was arranged in order to ask AEMPS some guidance in order to prepare the forthcoming submission of the phase IIa clinical trial for the iHIVARNA project. Read more
eCTD will become mandatory for ASMF/DMF
From January 2017 EDQM will require eCTD submissions for new applications for CEPs
eCTD New EU Module 1 Specification. Version 3.0.1
A new version of the EU eCTD Module 1 Specification (3.0.1) has been released, which can be used from 1st July 2015 and must be used from 1st October 2016. The new Module 1 specification was required for introduction of new submission type (redacted documentation of clinical data for the 0070 Transparency Policy, CEP and more), introduction of the Universal Unique Identifier (UUID) and the new field “submission units?.
Upcoming new THAI eCTD and Module 1
Did you know that Food and Drug Agency of Thailand is releasing new TH Module 1 with TH regional schema V1.0. eCTD submission?
We celebrated the Asphaconvention 2016
On 13th May, 2016 Asphalion held its annual convention where more than 70 employees attended. It was a sunny day full of activities that everyone enjoyed.
- 28 – 30 September 2016: BIOSPAIN, Bilbao, ES
- 28 – 30 September 2016: TOPRA Annual Symposium, Amsterdam, NL
- 4 – 6 October 2016: CPHI, Barcelona, ES
We do not close in August! We will be available to discuss your needs or requests as per normal.