News
School of Pharmacy hosts 2nd Annual Pharmaceutical Quality and Regulatory Science Symposium
The School of Pharmacy was delighted to host the second annual ‘Pharmaceutical Quality and Regulatory Science Symposium’ in the Pharmacy Building, UCC on December 5th 2023. The theme of this years meeting was ‘Beyond Compliance: Decision Driven Pharmaceutical Quality and Regulation’.
Over 60 delegates, representing local and national pharmaceutical manufacturing industry were addressed by a range of speakers, focusing on science led and risk-based decision making in pharmaceutical quality and regulation. Catherina O’Keeffe, QP and QA Team Lead in Janssen, and MSc PTQS alumnus, outlined her experience of ‘The Early Days in a QPs Career’, outlining the change of dynamics on moving into a batch release role. Valerie Mulholland from GMP Services and TU Dublin presented an analysis of 'Risk Based Decision Making - a game of chance or skill?' and discussed the opprtunitis and challenges associated with the revised ICH Q9 guidelines. She emphasized the importance of proactive decision-making by preparing for challenging, but foreseeable quality decisions in before they occur. Orla McCarthy, External Site Quality Lead and Associate Director/QP with MSD, and graduate of the MSc PTQS in the School, provided an outline of factors to consider in ‘Ensuring Quality Oversight in the External Manufacturing Space’. Orla specifically addressed the challenges which exist in decision making due to the remote nature of the manufacturing process. Finally, John Henchion of CAI outlined means of ‘Building a Mature Decision-Making Framework’ – focusing on effective communication, factual, science-based decision making and stakeholder management. The event also showcased poster presentations from the recent graduates of the MSc in Pharmaceutical Technology and Quality Systems. These posters outlined the work carried out during their dissertations and highlighted the potential impact of these research projects to industry representatives.
The symposium, led by Drs Joseph O’Shea and Patrick O’Dwyer, and Ms Linda McGuire, was established in 2022 with the aim of developing and promoting pharmaceutical industry targeted programmes within the school, through this annual networking event. The symposium provides an opportunity for graduates to present the research conducted during their dissertations to industry leaders through case study presentations. Industry experts are invited to share their knowledge on emerging themes in the pharmaceutical industry, focusing on quality, technical and regulatory snapshots to current students, graduates, and invited guests. The Organising Committee expresses gratitude to all those who participated, with special recognition to our esteemed speakers and poster presenters.
For those interested in being informed of future events please contact joseph.oshea@ucc.ie.