GCP Refresher Session
We welcome those looking to learn the new 2016 items added to the International Council on Harmonisation and Good Clinical Practice (ICH-GCP) standards.
This is a refresher session on ICH GCP E6 (R2) and will cover the responsibilities of all players in the clinical research field with a focus on changes by and impact of the 2016 GCP addendum for Investigators and Sponsors. This session will also cover local regulations, including recent updates to the Australian Code of Conduct and NHMRC Safety Guidelines.
Key components of the refresher session include:
- Refreshing Definitions and Principles of GCP
- Clinical Research and Regulations (including recent updates to the Australian Code of Conduct and NHMRC Safety Guidelines)
- ICH-GCP Responsibilities of Ethics Committees/ Investigators/Sponsors
- The essential GCP-related documents
- Changes by and impact of the 2016 GCP addendum for Investigators and for Sponsors
Join us for St John of God Subiaco Hospital's Research Week as Qatan Sagaale presents updates to ICH GCP E6 (R2).
After completing a degree in Laboratory Medicine, Qatan began working at Linear Clinical Research an early phase clinical trials facility, undertaking various roles including assisting/coordinating clinical trials before moving into the Quality Assurance department as a Quality Control Officer.
Qatan joined Telethon Kids Institute in 2016 as the Clinical Research Governance Coordinator. Alongside oversight and management of clinical research staff competencies, she is also responsible for maintaining the Institute's alignment to relevant regulatory requirements, including the Code for Responsible Conduct of Research and Good Clinical Practice (GCP).
She is responsible for developing and implementing clinical research policies and Standard Operating Procedures (SOPs) at the Institute and developing initiatives for improving current systems. She advises on ethics and governance throughout the Institute, and mentors researchers and students in their development, set-up and delivery of research projects.
Qatan also has GCP monitoring and auditing experience and was a content contributor for the online Good Clinical Practice (GCP) course developed by the WA Health Translation Network (WAHTN).
Date: Thursday 29 August 2019
Time: 7.00am to 7.15am breakfast, 7.15am to 8.45am refresher session
Venue: Conference Centre Auditorium, St John of God Subiaco Hospital, 25 McCourt Street Subiaco
Cost: $100 (does not apply to St John of God Health Care caregivers, TKI and UNDA employees).
To secure your place at this free event please visit our registration page, click on 'Book Now', select the event and complete your details.
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