Ivowen Limited hosts 2017 conference

Dublin, the venue It was our pleasure to host the EuDRAcon conference for 2017 in Ireland on 1st and 2nd of June.  We welcomed representatives from 21 Member States, including our new member from Cyprus, Nicolas Constantinou from Niconex Medical.  EuDRAcon currently has participating members in 25 of the current 31 EEA member states, plus […]

CESP expands in Poland and Greece

Latest news from Poland and Greece for CESP From 3rd April 2017 it will be possible to submit the following procedures via Common European Submission Portal (CESP) to Poland: Initial Marketing Authorisation Applications (MAAs) Variations Renewals The submissions may concern national and European procedures (MRP, DCP) both for human and veterinary medicinal products.   Also […]

ICH Elemental impurities

New ICH guideline Q3D on elemental impurities (EMA/CHMP/ICH/353369/2013)

Elemental impurities guideline What is it… The ICH has introduced this new guideline to control the elemental impurities that may be present in drug products. It replaces EMEA guidance on Specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000). This guideline applies to new drug products (with a new drug substance) and to […]

New ATC codes for 2017

The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted classification system for medicines.  This system is maintained by the World Health Organisation (WHO).  The WHO assigns ATC codes to all drug substances based on their therapeutic indication. The assigned ATC code must be present in your product information. What does this mean for you? […]

Ivowen attends EudraVigilance Training Course on Reporting of ICSRs/SUSARs in the EEA – Suspected Adverse Reactions to Medicines

What is EudraVigilance? EudraVigilance (http://eudravigilance.ema.europa.eu) is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA) and supports the safe and effective use of medicines (Figure 1 – EudraVigilance System Components).  Adverse reactions (ADRs) can be reported during the development […]

Onwards and upwards at Ivowen

I am delighted to announce the promotion of Alice D’Alton to the role of Regulatory Affairs and Business Manager. Alice has been an integral part of the team here in Ivowen for over three years and has more than 10 years experience working in the pharmaceutical industry. This new role within Ivowen will facilitate the […]

What do I do??

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 […]

HPRA Safety Features Workshop – update

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) […]

Where will we be in 2016?

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 […]