eCTD submission

Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software

FDA accepts PADER/PAER Submission in eCTD Format from June 10, 2015 onwards. The Regulatory industry is witnessing huge transformations. Some new regulations see the light of the day as we grow in the world of automation for regulatory compliance. Intervention of information technology for submission of periodic reports in pharmacovigilance is yet another required transformation.

eCTD submission

Questions & Answers Blog on recent webinar on ‘Solution to Periodic Safety Submissions Reports (PADER/PAER) in eCTD’

These are few of the questions raised by Webinar audience regarding Periodic Safety Submissions Reports (PADER/PAER) in eCTD Q 1. Is ICSR so called MedWatch Forms? Ans. ICSRs are Individual case safety reports that carries information on adverse event(s) reported for drug and can be submitted in XML format. MedWatch is FDA Form 3500A, a […]

eCTD submission

Draft revision of the EU M1 eCTD specification for public consultation

To accommodate several change requests submitted since version 2.0 was in force September 2013, a revision of the EU eCTD Module 1 Specification has taken place and is now published as a draft version 3.0 for public consultation. The updated specification (highlighted and clean) versions with relevant release notes and comments template are now available […]

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