exalon (@ectdexperts) header
exalon (@ectdexperts) profile picture

Latest news from Exalon and updates from Regulators, Pharmaceutical Industry and other Stakeholders.

Radolfzell (Germany)
Joined March 2010
Updated draft #eCTD v4.0 implementation timeline for EU now available esubmission.ema.europa.eu/eC…
49
Proposed timeline for the implementation of #eCTD v4.0 in the EU esubmission.ema.europa.eu/eC…
DADI - Common factors in the FHIR data standard for Art. 57(2) and eAF youtu.be/SUTlM3r_aYQ
Updated versions of the eAF v1.26.0.0 (bug fix version) now available esubmission.ema.europa.eu/ea…
FDA information regarding change in acceptance of submission types May 2017
How to request additional terms for the EU electronic Application Form?youtube.com/watch?v=-5Vh99Us…