Clinical Study Design for Medical Devices Focus of NUI Galway Symposium

Jun 06 2013 Posted: 10:42 IST

NUI Galway will host a symposiumonInnovative Clinical Study Design for Medical Devices’ on Wednesday, 12 June in Áras Moyola. Organised by the Biostatistics Unit at the HRB Clinical Research Facility, Galway (HRB CRFG), Ignite Technology Transfer Office and Metric Ireland, the symposium will be of interest to industry, clinicians and the biomedical research community.

Keynote speaker for the symposium will be Dr Gregory Campbell, who will address the audience on innovation in clinical study design, new guidance documents recently developed in the FDA and more. Dr Campbell is Director of Biostatistics Division in the Office of Surveillance and Biometrics within the Center for Devices and Radiological Health (CDRH) at the Food and Drugs Administration (FDA). He currently leads a group of over 55 statisticians at the FDA, which provides statistical support to CDRH as a whole and, in particular, the statistical reviews of FDA’s pre-market device submissions.   

Dr John Newell, Head of the Biostatistics Unit at NUI Galway, said: “Dr Campbell leads a group of statisticians who research innovative methods to address the challenges in the evaluation of medical devices. We in the Biostatistics Unit are looking forward to interacting with Dr Campbell and learning how we can participate in advancing this field.”

Dr Sandra Ganly of Metric Ireland said: “The US Med Device market is the key market for all medical device companies, with the market expected to grow to $151 billion in 2015. Having an opportunity to understand the regulatory issues at play from Dr Campbell will provide the Irish-based companies which Metric Ireland assists, the ability to gain more timely, cost-effective regulatory approvals for their products and an opportunity to gain a foothold in this growing market.”

Other speakers will include NUI Galway’s Professor Martin O'Donnell, who will introduce the HRB CRFG and give an overview of capabilities and the facility's offering to industry; and John O'Dea of Crosspon, who will discuss the medical device cluster in Ireland, the success of the cluster and some of the challenges from a clinical trial design and execution perspective. The symposium will conclude with a panel discussion, where speakers will be joined by additional industry and clinical experts, and the delegates will get an opportunity to put forward their own questions to the experts.

Dr Jacinta Thornton, Acting Director of Ignite Technology Transfer Office (TTO), said: “This is a unique opportunity to access key opinion and guidance and is an event not to be missed if you are operating in the clinical and pre-clinical space in this sector. From our perspective at Ignite TTO, we are very much looking forward to learning from Dr Gregory Campbell and gaining the insights that will assist early stage companies in navigating the regulatory hurdles inherent with delivering their products to market.”

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