Event Date: 27/01/2010 01:00
The Irish Medicines Board is pleased to host this GCP Information Seminar in Dublin.
Aims of the Seminar
The purpose of the seminar is to outline GCP requirements, focusing particularly on those which are the responsibility of investigator site staff.
The programme will include Regulatory requirements, expectations and inspection findings relating to;
- the informed consent process
- safety reporting
- training
- IMP management
- protocol compliance
To view a detailed agenda, please click here.
Information Seminar Presentations
To view and/or print presentations in advance of the seminar please see below.
1. Clinical Trial Protocol - Compliance at Investigator Sites
2. Clinical Trials in Ireland - Regulatory Framework
3. Safety Reporting - Reporting of Adverse Events and Serious Adverse Events in Clinical Trials for Investigator Site Staff
4. Investigational Medicinal Product (IMP) Management
5. Informed Consent - Clinical Trial Subjects
6. Overview of the IMB's Approach to Inspection of Good Clinical Practice
7. Training & Delegation of Trial Duties - Training Requirements and Expectations, and Delegation of Duties for Investigator Site Staff
Who Should Attend
Investigators, Research Nurses, Study Coordinators, Site Data Managers
Fee & Venue Details
Venue: Camden Court Hotel, Camden St. Dublin 2
Times:
Registration begins at 10.00am
Presentation begins at 11.00am
Fee: There will be no fee for site staff.
Others: €200.00
Expressions of interest
Please indicate interest in attending by 15th January 2010 to reserve a place.
Delegates are invited to submit questions on any of the topics before 20th January 2010. Questions may also be raised during the seminar.
Registration:
Download registration form.
Completed registration forms may be emailed to compliance.infoday@hpra.ie
Or alternatively posted to:
GCP Information Seminar
Compliance Dept
Health Products Regulatory Authority
Earlsfort Terrace
Dublin 2
Refreshments
Tea / coffee will be provided at registration.
Lunch will be provided.
Contact for Seminar:
Nicola Mahon
Event Coordinator
Compliance Dept
Health Products Regulatory Authority
Earlsfort Terrace
Dublin 2
Tel: +353 (0)1 6764971