CESP delivery system updated

The latest CESP system, version 2.0, was officially launched on October 1st 2015 (https://cespportal.hma.eu). Ivowen Limited has been using this facility regularly and can help to guide you through any aspects that you may be struggling with. There are a few new features which sets it apart from the old version: The delivery file creation, […]

Regulatory Science Ireland (RSI) Seminar

Regulatory Science Ireland (RSI) Seminar, Cork, 8th September 2015 Ivowen Limited recently attended the Regulatory Science Ireland (RSI) Seminar hosted by Dr. Kevin O’Donnell (HPRA) and Professor Caitriona O’Driscoll (School of Pharmacy, UCC), which was followed by a round table interactive Q&A session. RSI is a new organisation that carries out research and education in […]

PSUR repository updated

On the 26th of January 2015, the EMA introduced the pilot phase on the use of the XML delivery file for submissions of PSURs via the eSubmission Gateway/Web Client. This introduction, 1) Simplified package file names for PSURs and 2) Introduced the requirement of an XML delivery file. The XML delivery file is created in […]

EMA introduces changes to the QRD templates

The EMA has introduced changes to the QRD templates of the product information that accompany all medicines authorised for use in the EU including package leaflet (PL) and the summary of product characteristics (SmPC). Full details are available here: Summary of Main Changes: The changes to Quality Review of Documents (QRD)  templates are detailed in […]

Update on the future of electronic submissions (eCTD)

Ivowen Limited recently attended the annual EuDRAcon conference in Lörrach, hosted by the German representative, Finkler. [EuDRAcon is an abbreviation for European Drug Regulatory Affairs Consultants. It is a pan-European network of regulatory affairs consultancy companies dealing with drugs, medical devices, cosmetics and food supplements] We began the event by voting in the newest member […]

Impact of Paediatric Legislation on Regulatory Strategy Information Day.

Ivowen Limited recently attended Topra’s Reviewing the Impact of Paediatric Legislation on Regulatory Strategy Information Day.   On the morning of the solar eclipse the clouds may have left us feeling disappointed, however the silver lining was definitely the frank and honest presentations regarding the PIP legislation which followed that day.   Paolo Tomasi, Head […]