2019 – What a year

Ivowen Limited attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November. We all saw Brexit come and go, Twice !! We wait to see what lies in store for the […]

Ivowen attended TOPRA Symposium 2019

This year’s TOPRA Annual Symposium was held in Dublin in October. The Annual Symposium is an essential meeting for regulatory professionals to gain both an understanding of current and evolving regulatory requirements, as well as insights into future plans for regulations in the Human medicines, Veterinary medicines and Medical Device sectors. Three members of our […]

Company Announcement – Majella Ryan FTOPRA

Ivowen Limited are pleased to announce that Fellowship of The Organisation for Professionals in Regulatory Affairs (FTOPRA) has been conferred on Majella Ryan.  According to TOPRA: “The award of a Fellowship is intended to recognise a contribution in which the individual has used his/her professional knowledge and experience to influence, guide or develop the profession in […]

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 […]

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 […]