You can find a copy of the final agenda at this link.
Session 1 - Update on legislation and guidance
Chair: John Lynch, Director of Compliance
Update of Clinical Trials Regulation EU No 536/2014 - Agnieszka Przybyszewska, Senior Medical Officer
Good Clinical Practice – review of recent and future changes to relevant guidance - Sinead Curran, GCP/PV inspection manager
Overview of HPRA GCP inspections and common findings - Peter Twomey, GCP/PV inspector
Expectations for GCP compliance: data integrity - Marie Callaghan, GCP/PV inspector
Update of Clinical Trials Regulation EU No 536/2014 - Agnieszka Przybyszewska, Senior Medical Officer
Good Clinical Practice – review of recent and future changes to relevant guidance - Sinead Curran, GCP/PV inspection manager
Session 2 - GCP inspections and compliance
Chair: Anne Hayes, Inspection Manager
Overview of HPRA GCP inspections and common findings - Peter Twomey, GCP/PV inspector
Expectations for GCP compliance: data integrity - Marie Callaghan, GCP/PV inspector
Session 3 - Clinical trial sponsorship: focus on non-commercial sponsors
Chair: Elaine Breslin, Clinical Assessment Manager
Sponsoring a clinical trial, expectations for quality systems, risk management and monitoring - Sinead Curran, GCP/PV inspection manager
Pharmacovigilance systems - Peter Twomey, GCP/PV inspector
Investigational medicinal product management - Marie Callaghan, GCP/PV inspector
Sponsoring a clinical trial, expectations for quality systems, risk management and monitoring - Sinead Curran, GCP/PV inspection manager
Pharmacovigilance systems - Peter Twomey, GCP/PV inspector
Investigational medicinal product management - Marie Callaghan, GCP/PV inspector
