Innovative Clinical Study Design for Medical Devices, June 12th 2013
Welcome

 

 

 

Innovative Clinical Study Design

 

for Medical Devices 


Date: 12th June 2013

 

Venue: Áras Moyola, NUI Galway

 

 

Dr. Gregory Campbell

US Department of Health and Human Services,

Food and Drugs Administration,

Center for Devices and Radiological Health, Maryland, USA

 

 

If you are interested in hearing about clinical trial design and execution, protocols and methodologies in relation to IDE, PMAs, 510K submissions as a global hub in the medtech space, this symposium is a must for you.

 

Join the HRB Clinical Research Facility Galway, Ignite Technology Transfer Office & MetricIreland in NUI Galway for this Symposium – Innovative Clinical Study Design for Medical Devices at 10.00a.m. on Wednesday 12th June 2013 at Áras Moyola, NUI Galway.  This symposium will be of interest to the research community as well as our industrial partners.

 

 

 

  

If you are interested in hearing about clinical trial design and execution, protocols and methodologies in relation to IDE, PMAs, 510K submissions across jurisdictions, First-in-Human Studies, types of pivotal clinical study designs, innovation in the post-market arena then this is the event for you.

 

Join the HRB Clinical Research Facility, Galway, Ignite Technology Transfer Office & MetricIreland in NUI Galway for a Symposium - Innovative Clinical Study Design for Medical Devices from 10am on Wednesday 12th June 2013 at Aras Moyola, NUI Galway.  This symposium will be of interest to industry, clinicians and the biomedical research community.

  

NUI Galway is delighted to welcome Dr. Gregory Campbell, Food and Drugs Administration (FDA) as our keynote speaker for this symposium. Dr. Campbell is the Director of Biostatistics Division in the Office of Surveillance and Biometrics (OSB) within the Center for Devices and Radiological Health (CDRH) at the FDA.

 

The HRB Clinical Research Facility, Galway (CRFG) has been in operation since March 2008. The Director of the HRB Clinical Research Facility, Galway, Professor Martin O’Donnell will introduce the CRFG and give an overview of capabilities and the facility’s offering to industry. Mr.   John O’Dea, Crosspon, will then speak on the medical device cluster in Ireland, the success of the cluster and some of the challenges from a clinical trial design and execution perspective. Dr. Campbell, the keynote speaker, will then address the audience on innovation in clinical study design, new guidance documents recently developed in the FDA and more.  The symposium will conclude with a panel discussion, where the speakers will be joined by additional industry and clinical experts, and you will get an opportunity to put forward your own questions to the experts.