Ivowen Limited will be attending the upcoming 9th EGA Pharmacovigliance, and the 15th EGA Regulatory and Scientific Affairs Conference in London from from 27th-29th January. Please contact us if you would like to arrange a meeting.
Ivowen Limited summarise TOPRA Annual Human Medicines Symposium 2015
Alice D’Alton from Ivowen Limited was delighted to be asked to provide a summary of Session 4 at the recent TOPRA Annual Human Medicines Symposium 2015. The full summary is provided in the following link: SESSION 4: Globalisation of pharmaceutical regulation – What do agencies discuss behind closed doors? For further information or if you […]
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, […]
Ivowen Limited to Attend CPhI Conference – October 2015
Ivowen Limited will be attending the upcoming CPhI conference in Madrid on 13th-14th October. Please contact us if you would like to arrange a meeting.
Ivowen to Attend TOPRA Annual Symposium – October 2015
Ivowen Limited will be attending the upcoming TOPRA’s annual symposium in Berlin from 12th-14th October. Please contact us if you would like to arrange a meeting.
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 […]
