Good Clinical Practice in Medical Device Research (ISO14155) – HRB Clinical Research Facility Cork & Infant
This course is aimed at Investigators, Research Nurses and other personnel who are planning to conduct (or actively engage in) a clinical Investigation of a medical device. Course contents include :
- Medical Device Definitions and Classification
- Regulation and Governance
- Conduct of Device Investigations
- PI Responsilities
- Quality in Clinical Investigations (Monitoring/ Audit) & Safety Reporting
Date: Weds 20th November 2019 9.30 am to 14.30 pm
Location: UCC Brookfield Health Sciences Complex – Room 303
Cost: Registration €50 Student Rate €25
Contact Aoife Quinlan to reserve a place on the course or if you have any further queries
Presenters :
Dr Ruben Keane, BSc (Hons), PhD, H. Dip Applied Psych.
Ruben has over 12 years in Clinical Research having worked within Pharmaceutical Company (MMD, France), Contract Research Organizations (ICON and Quintiles Ireland) and Academic institutions (Trinity College Dublin and University College Cork) in a variety of roles in the areas of Quality, Regulatory Affairs and Pharmacovigilance and Project Management.
In her current role of Quality and Regulatory Affairs Director at the HRB-Clinical Research Facility Cork (2014 to date) she developed and implemented a quality management system (QMS), and assists investigators with regulatory submissions (IMP and Device Trials). She assists Dr Muiris Dowling (Clinical Research Reporting Officer at UCC) in overseeing Regulatory compliance, Pharmacovigilance and Quality for UCC sponsored trials. This includes carrying out sponsor audits (IMP and Devices) on behalf of UCC
Jackie O’Leary, RGN, Dip in Quality Management, BBus (Hons), MSc in Clinical Trials
Jackie O’Leary is the Quality & Regulatory Affairs Manager for INFANT, an ISO 9001:2015 accredited academic research centre and qualified as a general nurse in 1988. She commenced her career in research in 1990 and since 2000 she has worked in the area of Quality Control/Assurance and monitoring. Jackie completed a Diploma in Quality Management in 2006, has achieved a first class honours degree in Business (BBUS) from Cork Institute of Technology in 2012, and in 2014 received a Master’s in Clinical Trials with honours from The London School of Hygiene and Tropical Medicine.
She is the coordinator for the Quality Management System (QMS) implementation. Her responsibilities include overall management of the QMS for INFANT including implementing policies and procedures for compliance with regulatory guidelines incorporating Good Clinical Practice, (GCP) and ISO standards. This includes generation of generic Standard Operating Procedures (SOPs) for the centre including document control and archiving and the quality control of these processes.
Both Ruben and Jackie are experienced in developing and delivering training to investigators and trial personnel in all aspects of clinical trial conduct including GCP for both IMPs and devices. Drawing on their experience within Clinical Research they use relevant examples and are both skilled and engaging presenters.
