Update for week of 15 February 2016

DIT joins forces with FDA for special edition of leading Pharmaceutical Industry Journal

The Pharmaceutical Regulatory Science Team (PRST) at DIT, in collaboration with the US Food and Drug Administration (FDA), the Irish Health Products Regulatory Authority (HPRA) and several other industry thought leaders, broke new ground by contributing every article for the year-end, double-size edition of the peer reviewed Journal of Validation Technology (JVT). 

Asking if our medicines are safer now, the issue addresses a review of risk management practices within the pharmaceutical industry to commemorate the tenth anniversary of the publication of the international regulatory guidance, ICH Q9 - Quality Risk Management.

The JVT editorial team commended DIT for co-ordinating the issue, stating it, "features the brightest minds from one of Europe’s top schools and embodies the industry-leading expertise of the DIT". Noting that the articles outline FDA perspectives, strategies for leadership, regulations' effectiveness, ”this special issue is the state of the art for quality scholarship and practices.” 

Congratulations are due to the PRST team Dr. Anne Greene, Dr. Nuala Calnan (Adjunct Research Fellow), Kelly Waldron (PhD Candidate) and Dr. Kevin O’Donnell (HPRA) for their achievement.

For more details contact Dr. Anne Greene at anne.greene@dit.ie