Regulatory information – European Medicines Agency organises training sessions on eSubmission Gateway and web client for PSUR single-assessment submissions
The European Medicines Agency is organising training sessions on the use of the eSubmission Gateway and web client to submit periodic safety update reports (PSURs) subject to the single-assessment procedure.
These training sessions are intended for all applicants submitting single-assessment PSURs in the electronic-common-technical-document (eCTD) or non-eCTD electronic-submission (NeeS) formats through the eSubmission Gateway and the web client. The sessions cover aspects such as registration, filename conventions, and receipts and acknowledgements received by applicants.
Each webinar has 95 places. Places on both sessions will be allocated on a first-come-first-served basis. The sessions are taking place on:
- 16 July 2013 at 15.00-16.30 United Kingdom (UK) time;
- 1 August 2013 at 09.30-11.00 UK time.
To book a place, e-mail email@example.com.
The Agency started carrying out single assessments of PSURs of active substances contained in both centrally and nationally authorised medicines in April 2013.
Single assessment of PSURs is a deliverable of the 2010 pharmacovigilance legislation, which has given the Agency the responsibility to analyse all reports for medicines containing a particular active substance, for all types of marketing authorisation and for medicines authorised in more than one Member State.
- eSubmission Gateway and eSubmission web client
- How to submit periodic safety update reports for European Union single assessment of substances contained in both centrally authorised products and nationally authorised products to the European Medicines Agency
- European Union reference dates and submission of periodic safety update reports
- Guidance on submission of single-assessment PSURs published (24/06/2013)