Congratulations to the first graduants from Specialist Dip. in (Bio) Pharmaceutical Regulatory Affairs

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SSPC are delighted to announce the first official graduates from the Specialist Diploma in (Bio) Pharmaceutical Regulatory Affairs, a course developed in association with the Department of Chemical Sciences and School of Graduate and Professional Studies at the University of Limerick.

The background to the programme and curriculum development involved the recognition that there is no single qualification required to work in Regulatory Affairs – notwithstanding the fact that it is a critical and pivotal role, making safe and effective medicines available to patients worldwide. It is an acquired professional skill, with entrants coming from a wide range of backgrounds within industry – quality, manufacturing, pharmaceutical analysis, formulation and development among others, or life sciences graduates with primary qualifications in pharmacy or the biological, biopharmaceutical or chemical sectors. To date, accredited RA training has not been available in Ireland.

The delivery of the UL Specialist Diploma in (Bio) Pharmaceutical Regulatory Affairs is via a blended learning approach, and with on-site attendance on just a few (5-6) Saturdays per annum, appeals to both employers and students in Ireland. Accreditation at level 9 (Graduate level – National Qualifications Framework) from the University of Limerick also offers a natural career progression for the majority of graduates working in regulatory affairs.

This Specialist Diploma benefits those in the early stages of their regulatory career as well as more experienced professionals seeking to enhance their knowledge or formalise their learning.

Guest lecturers from regulatory agencies such the CEO of the MHRA in the UK and many speakers from the HPRA in Ireland were brought in to offer students exposure to the regulator’s perspective. A key contact in the European Commission, Dr Fergal Donnelly was also invited as a guest lecturer to offer students a European perspective of the long-term view the EU is taking in this space. Providing this broader contextual understanding of the regulatory landscape is a distinctive facet of this course, and offers participating students unique perspectives and connections in the regulatory space.

The programme’s external examiner is a very experienced and competent industry expert – Dr Nancy Pire-Smerkanich, Assistant Professor of Regulatory Affairs, University of Southern California. This we feel ensures that our delegates have unprecedented access in Ireland to a global team of regulatory experts.

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