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, 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 […]
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 […]
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 […]
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 […]
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 […]
Marketing Authorisation Applications for human use submitted using the Decentralised Procedure (DCP) will need to be provided electronically as eCTD by Q3 2015. Submission in eCTD for Mutual Recognition Procedures (MRP) will also be required by the start of 2017, and finally National Procedures by the start of 2018. eCTD is already required for Centralised […]
Majella is delighted to have been asked to speak at the LEO Forum on Female Entrepreneurship this Wednesday, 22 April. Book your place now: https://www.localenterprise.ie/Tipperary/Training-Events/Online-Bookings/?date=22%2F4%2F2015
Are you an experienced Regulatory Affairs professional looking for a new challenge in a dynamic and fast-moving consultancy? Then we may be the fit for you. Have a look at our requirements on our Vacancies page here and send in your CV if interested. Of course, we are always interested in receiving inquiries from people […]
Majella Ryan and Fiona Downey will be attending the EGA conference in London from 21st to 23rd January 2015. Please contact us if you would like to arrange a meeting!