In my circle of friends I feel like I am the “Chandler Bing” and it’s not because I am the funny one; no, it’s because no one knows or understands what I do for a living. My mother still believes I work in a laboratory and have a working knowledge of all medicines and once […]
Ivowen recently attended the HPRA Safety Features Workshop Athlone (3rd May 2016). The following is a summary of the key take-home points from this workshop. Introduction of a Unique Identifier (UI) and Anti-tampering Device (ATD) on Packaging of POM and Certain OTC Medicines Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) […]
We are already in Quarter 2 of 2016 and as it comes to the end of April we thought it necessary to update current and potential clients as to where we will be and where you can meet us in 2016. As a company providing expert advice and support to our clients we at Ivowen […]
Falsified medicines are fake medicines that are designed to mimic real medicines. Due to the increase of falsified medicines on the market the EU has a strong legal framework for licensing, manufacturing and distribution of medicines. In July 2011 DIRECTIVE 2011/62/EU (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF ) came into force; this directive aims to prevent falsified medicines entering the […]
General The eAF is mandatory for all procedures from 01/01/2016 (CP, MR, DC, National in eCTD/NeeS/Paper). However, Presubmission Meeting Requests, Article 61(3) & MAT forms remain the outside scope and can be submitted as paper or PDFs. Please contact us if you require any assistance with any of the forms or any advice on any […]
Ivowen 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.
Alice D’Alton from Ivowen 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 have […]
The latest CESP system, version 2.0, was officially launched on October 1st 2015 (https://cespportal.hma.eu). Ivowen 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, has […]
Ivowen 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 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 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 the […]
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 […]
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Co. Waterford, X35 FX45,
Ireland.