Trial set-up: The Importance of Project Management
Mr Damien O’Driscoll, Academic Trial Coordinator, HRB CRF-C
The Role of the Research Nurse in Regulated Studies – Knowing What is Feasible
Ms Maeve Kelsey, Clinical Trial Manager, HRB CRF-C
Data Management
Dr Evelyn Flanagan, Data Manager, HRB CRF-C
Data Protection, Common Pitfalls
Ms Audrey Huggard, OCLA, UCC
Networking Clinical Trials
Ms Anna Shevlin, Clinical Trial Liaison Officer, HRB CRCI
Regulatory Aspects of Clinical Trials
Dr Ruben Keane, Quality and Regulatory Affairs Manager, HRB CRF-C
Pharmacovigilance Requirements
Ms Sinéad Curran, Quality and Regulatory Affairs Manager, HRB CRCI
What to Expect from a Regulatory Inspection Clinical Trials (Medicines)
Ms Deirdre O’Regan, GCP/PhV Inspection Manager, HPRA
IMP management in HPRA regulated Clinical Trials
Dr Ruben Keane, Quality and Regulatory Affairs Manager, HRB CRF-C
Regulatory Science Ireland
Prof Caitriona O’Driscoll, RSI
Regulatory Viewpoint, Clinical Investigations (Medical Devices)
Mr Niall MacAleenan, Devices HPRA
Challenges of conducting a Clinical Investigation of a Medical Device in Academia
Ms Taragh Keily
