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Dr. Ruben Keane

Director of Quality and Regulatory Affairs

Ruben has over 15 years’ experience of Clinical Research in a variety of settings including Pharmaceutical (Marion Merrell Dow, France), Contract Research Organisations (ICON and Quintiles, Dublin) and Academic settings (Trinity College Dublin and University College Cork). She joined the HRB-Clinical Research Facility- Cork as Director of Quality and Regulatory Affairs in 2014.

Ruben’s qualifications include BSc (2:1 H -1985), PhD (1989) Higher Diploma in Applied Psychology (1H – 2011). She is currently undertaking a Masters in Pharmaceutical Medicine at Trinity College Dublin.

Ruben has extensive experience in Quality, Regulatory and Pharmacovigilance for Clinical Trials gained during her roles as Clinical Research Associate (Marion Merrell Dow, France and ICON Dublin), Associate Director of Drug Safety (Quintiles Dublin), Project Manager (Trinity College Dublin), Data Manager (Oral Health Services Research Unit, UCC) and in her current role as Director of Quality and Regulatory Affairs at HRB-HRB CRF-C.

She carries out Regulatory submissions to HPRA for Clinical trials and Clinical Investigations (Devices), and is Sponsor Auditor for UCC sponsored trials. She regularly delivers courses including ICH-GCP, Introduction to Clinical Research, and GCP for Medical Devices (ISO14155) both within UCC and as guest lecturer