RCSI: Upcoming Seminars in GCP and Medical Device Research

INTRODUCTION TO CLINICAL RESEARCH & GOOD CLINICAL PRACTICE

RCSI Education and Research Centre, Beaumont Hospital

Thursday 14th September, 2023, Tutorial Room 1,  9.00 – 16.00
This course is relevant to Principal Investigators, research nurses/midwives, monitors and research site personnel who have not undertaken GCP training within the previous 2 years. Content is based on ICH E6 (R2) 2016, and includes the key requirements of the Clinical Trial Regulations (536/2014) and national legislation. The following content is included:

  • Introduction to Drug Development and Clinical Research
  • Clinical Research Governance & Principles of Good Clinical Practice
  • Investigator Responsibilities
  • Quality and Safety Issues

The course has Category 1 Approval from the Nursing & Midwifery Board of Ireland (NMBI). It also meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma as necessary to enable mutual recognition of GCP training by trial sponsors

For further information or to reserve a place contact Deirdre Hyland – dhyland@rcsi.ie

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GOOD CLINICAL PRACTICE IN MEDICAL DEVICE RESEARCH

RCSI Education & Research Centre, Beaumont Hospital

Wednesday 27th September, 2023, 09.30 – 16.00
A one-day course aimed at investigators, project managers, research nurses and other research team members involved in the conduct of medical device research at a clinical research site.  It is also relevant to sponsors and device manufacturers involved in organizing and initiating clinical investigations.  The course is based on the requirements of the Medical Device Regulations and ISO 14155, and includes the following content:

  • Principles of Good Clinical Practice in Medical Device Research
  • Medical Devices (What is a Medical Device; Types & Classification; Medical Device Legislation; Clinical Investigations)
  • Good Clinical Practice in Device Trials (Ethical Issues; Planning and Conducting a Clinical Investigation)
  • Safety Reporting in Device Research; Monitoring & Audit

For further information or to reserve a place please contact Deirdre Hyland – dhyland@rcsi.ie

29 August 2023

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