Asphanews June!

Asphanews June!

Asphanews Summer 2016
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

Read more
 
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?. Read more
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?

Read more
 

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.
 

Upcoming Events

28 – 30 September 2016

BIOSPAIN  

Bilbao, ES



28 – 30 September 2016

TOPRA Annual Symposium

Amsterdam, NL



4 – 6 October 2016

CPHI 

Barcelona, ES

 

August Open!

We do not close in August! We will be available to discuss your needs or requests as per normal.

See you at... CPHI, Biospain and TOPRA
Do you want to know more about ISO IDMP implementation?

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