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 Trial set-up: The Importance of Project Management 

Mr Damien O’Driscoll, Academic Trial Coordinator, HRB CRF-C

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The Role of the Research Nurse in Regulated Studies – Knowing What is Feasible

Ms Maeve Kelsey, Clinical Trial Manager, HRB CRF-C

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Data Management

Dr Evelyn Flanagan, Data Manager, HRB CRF-C

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Data Protection, Common Pitfalls


Ms Audrey Huggard, OCLA, UCC

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Networking Clinical Trials

Ms Anna Shevlin, Clinical Trial Liaison Officer, HRB CRCI

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Regulatory Aspects of Clinical Trials

Dr Ruben Keane, Quality and Regulatory Affairs Manager, HRB CRF-C

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Pharmacovigilance Requirements

Ms Sinéad Curran, Quality and Regulatory Affairs Manager, HRB CRCI 

HPRA

What to Expect from a Regulatory Inspection Clinical Trials (Medicines)

Ms Deirdre O’Regan, GCP/PhV Inspection Manager, HPRA

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IMP management  in HPRA regulated Clinical Trials

Dr Ruben Keane, Quality and Regulatory Affairs Manager, HRB CRF-C

RSI

Regulatory Science Ireland

Prof Caitriona O’Driscoll, RSI

HPRA

Regulatory Viewpoint, Clinical Investigations (Medical Devices)

Mr Niall MacAleenan, Devices HPRA

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Challenges of conducting a Clinical Investigation of a Medical Device in Academia

Ms Taragh Keily

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