eCTD.it UserGroup

A fine maggio Swissmedic nella sezione Project SIMES: eCTD Pilot Submissions ha annunciato la ricerca di aziende farmaceutiche che siano disponibili a fare delle submission pilot in eCTD nel periodo 1 Giugno-31 Agosto 2009.

Può essere interessante rivedere le principali milestone del progetto SIMES di Swissmedic come riportate sul sito swissmedic:

Milestones within the introduction of Swissmedic eSubmissions system
Implementing eSubmissions within the SIMES project includes the following milestones:

Milestone 1: as of March 2009: publication of project information on the Swissmedic website
Milestone 2: July 2009: first version of the eCTD specifications and Swissmedic practical guidelines ready for feedback and review.
Milestone 3: October 2009: revised eCTD specifications and practical guidelines are released.
Milestone 4: January 2010: going live. Submissions in eCTD format authorised for certain types of applications.
Milestone 5: March 2010: follow-up evaluation and adjustments.