Training & Conferences

The Wellcome Trust HRB Clinical Research Facility, St. James’s Hospital will host “Introduction to GCP” training courses for Investigators and Site Staff on the following dates:

• Fri 27^th July 2018
• Mon 10th Sept 2017
• Fri 16^th Nov 2018

The courses provides training for investigators and site research staff on ICH E6 (R2) (GCP).  The course includes a brief introduction to the national regulatory framework, Principles of ICH-GCP, Investigator Responsibilities and Essential Documents.  The course is delivered with a practical focus and provides workshops and opportunities for discussion.

Each course running from 2-5pm.

View the poster overview for the course here.

For further information or to book a place on one of the upcoming courses, please contact Anna Burzanowska at burdzana@tcd.ie

The Wellcome Trust HRB Clinical Research Facility, St. James’s Hospital will host “Introduction to GCP” training courses for Investigators and Site Staff on the following dates:

• Mon 10th Sept 2017
• Fri 16^th Nov 2018

The courses provides training for investigators and site research staff on ICH E6 (R2) (GCP).  The course includes a brief introduction to the national regulatory framework, Principles of ICH-GCP, Investigator Responsibilities and Essential Documents.  The course is delivered with a practical focus and provides workshops and opportunities for discussion.

Each course running from 2-5pm.

View the poster overview for the course here.

For further information or to book a place on one of the upcoming courses, please contact Anna Burzanowska at burdzana@tcd.ie

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 conducting clinical investigations.  This course includes the following content:

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

RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital

Cost: €100.00 (Clinical/Academic rate),  €200.00 (Industry rate)

Contact: Deirdre Hyland    (01) 809 3785  dhyland@rcsi.ie

GCP Full Course– HRB Clinical Research Facility Cork

Course Overview:

The Clinical Research Facility-Cork offer refresher courses in ICH-Good Clinical Practice for Investigators and Site Personnel.

The following content is included:

• Rules & Regulations governing Clinical Research (only FULL)
• Principles of Good Clinical Practice
• Investigator Responsibilities

This course meets the minimum criteria for ICH GCP Investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

The course has category 1 Bord Altranais approval for Continuing Education Units (CEU). Physicians who attend are eligible for Continuing Professional Development (CPD) points from the Royal College of Physicians in Ireland (RCPI).

The course has been developed and will be delivered by CRF-C Quality and Regulatory Affairs Manager, Dr Ruben Keane and CRF-C Monitor Ms. Maire McCarthy.

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact us at lucy.deane@ucc.ie

The 4 hour ICH GCP course will take place on the following dates:

Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP)

The National Children’s Research Centre, Our Lady’s Children’s Hospital Crumlin, will host ‘Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP)’ training courses for Investigators and associated research site personnel.

This one-day course is relevant to Principal Investigators, research nurses and associated research site personnel who have not undertaken GCP training within the previous 2 years.

The course provides training for investigators and site research staff on ICH E6 (R2) (GCP).

The following content is covered in the course:

• Introduction to Paediatric Drug Development and Clinical Research
• Research Governance
• Principles of ICH-GCP
• Investigator Responsibilities
• Essential Documents
• Regulatory Inspections

It also includes practical workshops and opportunities for discussion.

The course is accredited by the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs. 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 among trial sponsors.

For further information or to book a place on one of the upcoming courses, please contact gcptraining@ncrc.ie

Course dates for 2018 are : Tuesday 3rd July, Monday 24th Sep and Wednesday 28th Nov. All courses run from 8.30 a.m. to 2.30 p.m.

Venue: Seminar Room, National Children’s Research Centre, Gate 5, Our Lady’s Children’s Hospital Crumlin

Registration is required as places are limited. Certificates will be provided on the day

The NCRC is providing the course at no cost to paediatric clinical research staff

Additional dates can be facilitated at alternative locations for groups of 10 or more.

A one day course aimed at investigators, project managers and associated research team members involved in investigator-led clinical trials, representatives from the pharmaceutical industry and research officers from academic institutions. The following content is included:

• Clinical Research Governance: Background, Rules and Regulations
• Principles of Good Clinical Practice
• Sponsor Responsibilities

Regulatory Inspections (Sponsor Perspective)

Cost: €100.00 (Clinical/Academic rate), €200.00 (Industry rate)

Contact: Deirdre Hyland   (01) 809 3785 dhyland@rcsi.ie

GCP Refresher Course– HRB Clinical Research Facility Cork

Course Overview:

The Clinical Research Facility-Cork offer refresher courses in ICH-Good Clinical Practice for Investigators and Site Personnel.

The following content is included:

• Principles of Good Clinical Practice
• Investigator Responsibilities

This course meets the minimum criteria for ICH GCP Investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

The course has category 1 Bord Altranais approval for Continuing Education Units (CEU). Physicians who attend are eligible for Continuing Professional Development (CPD) points from the Royal College of Physicians in Ireland (RCPI).

The course has been developed and will be delivered by CRF-C Quality and Regulatory Affairs Manager, Dr Ruben Keane and CRF-C Monitor Ms. Maire McCarthy.

The 2 hour 30 mins refresher ICH GCP course will take place on the following dates:

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact us at lucy.deane@ucc.ie

Course Dates:

GCP Full Course– HRB Clinical Research Facility Cork

Course Overview:

The Clinical Research Facility-Cork offer refresher courses in ICH-Good Clinical Practice for Investigators and Site Personnel.

The following content is included:

• Rules & Regulations governing Clinical Research (only FULL)
• Principles of Good Clinical Practice
• Investigator Responsibilities

This course meets the minimum criteria for ICH GCP Investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

The course has category 1 Bord Altranais approval for Continuing Education Units (CEU). Physicians who attend are eligible for Continuing Professional Development (CPD) points from the Royal College of Physicians in Ireland (RCPI).

The course has been developed and will be delivered by CRF-C Quality and Regulatory Affairs Manager, Dr Ruben Keane and CRF-C Monitor Ms. Maire McCarthy.

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact us at lucy.deane@ucc.ie

The 4 hour ICH GCP course will take place on the following dates:

The Wellcome Trust HRB Clinical Research Facility, St. James’s Hospital will host “Introduction to GCP” training courses for Investigators and Site Staff on the following date:

• Fri 16^th Nov 2018

The course provides training for investigators and site research staff on ICH E6 (R2) (GCP).  The course includes a brief introduction to the national regulatory framework, Principles of ICH-GCP, Investigator Responsibilities and Essential Documents.  The course is delivered with a practical focus and provides workshops and opportunities for discussion.

The course runs from 2-5pm.

View the poster overview for the course here.

For further information or to book a place on one of the upcoming course, please contact Anna Burzanowska at burdzana@tcd.ie

This one day course is relevant to Principal Investigators, research nurses and associated research site personnel who have not undertaken GCP training within the previous 2 years. The following content is included:

• Introduction to Drug Development and Clinical Research
• Research Ethics and Clinical Research Governance
• Principles of Good Clinical Practice
• Investigator Responsibilities
• Regulatory Inspection

The course has Category 1 Approval from the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs. 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 among trial sponsors.

Cost:  €100.00 (Clinical/Academic rate), €200.00 (Industry rate)

Contact:  Deirdre Hyland,  (01) 809 3785 dhyland@rcsi.ie

Tuesday 20^th November 2018.

RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital.

Additional dates can be facilitated at alternative locations for groups of 10 or more.

Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP)

The National Children’s Research Centre, Our Lady’s Children’s Hospital Crumlin, will host ‘Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP)’ training courses for Investigators and associated research site personnel.

This one-day course is relevant to Principal Investigators, research nurses and associated research site personnel who have not undertaken GCP training within the previous 2 years.

The course provides training for investigators and site research staff on ICH E6 (R2) (GCP).

The following content is covered in the course:

• Introduction to Paediatric Drug Development and Clinical Research
• Research Governance
• Principles of ICH-GCP
• Investigator Responsibilities
• Essential Documents
• Regulatory Inspections

It also includes practical workshops and opportunities for discussion.

The course is accredited by the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs. 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 among trial sponsors.

For further information or to book a place on one of the upcoming courses, please contact gcptraining@ncrc.ie

Course dates for 2018 are : Tuesday 3rd July, Monday 24th Sep and Wednesday 28th Nov. All courses run from 8.30 a.m. to 2.30 p.m.

Venue: Seminar Room, National Children’s Research Centre, Gate 5, Our Lady’s Children’s Hospital Crumlin

Registration is required as places are limited. Certificates will be provided on the day

The NCRC is providing the course at no cost to paediatric clinical research staff

Additional dates can be facilitated at alternative locations for groups of 10 or more.

GCP Refresher Course– HRB Clinical Research Facility Cork

Course Overview:

The Clinical Research Facility-Cork offer refresher courses in ICH-Good Clinical Practice for Investigators and Site Personnel.

The following content is included:

• Principles of Good Clinical Practice
• Investigator Responsibilities

This course meets the minimum criteria for ICH GCP Investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

The course has category 1 Bord Altranais approval for Continuing Education Units (CEU). Physicians who attend are eligible for Continuing Professional Development (CPD) points from the Royal College of Physicians in Ireland (RCPI).

The course has been developed and will be delivered by CRF-C Quality and Regulatory Affairs Manager, Dr Ruben Keane and CRF-C Monitor Ms. Maire McCarthy.

The 2 hour 30 mins refresher ICH GCP course will take place on the following dates:

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact us at lucy.deane@ucc.ie