Addressing Operational and Technical Challenges in Home-use Point-of-Care Device Development and Deployment

Technological innovations, market needs, and evolving regulatory requirements have led to a rapid growth in Point of Care (POC) testing and devices. This webinar will help you understand the use of POC devices to support clinical research, learn key development and regulatory requirements for POC devices and use decentralized study models to support evidence generation for POC development.

Register Free: http://www.appliedclinicaltrialsonline.com/act/poc

Event Overview:

Technological innovations, market needs, and evolving regulatory requirements have led to a rapid growth in Point of Care (POC) testing and devices. POC testing involves medical diagnostic tests performed outside a laboratory environment, and increasingly in the home setting. Home-use devices aid in the early detection of potential health conditions in the absence of symptoms, facilitate early and more optimal treatment interventions and reduce the burden on healthcare systems. The evolution of home-use devices and changing regulatory landscape and evidence requirements presents challenges for clinical researchers that require innovative and robust operational and technical solutions.

Key Learning Objectives:

  • Study models to support evidence generation for home-use device development
  • Technological approaches to integrating data from home-use devices to support clinical research
  • Key development and regulatory requirements for home-use devices

Who Should Attend:

Pharmaceutical, biotechnology, medical device, and diagnostics companies – areas within companies: data analysis, health economics, outcomes research, medical affairs, clinical research, clinical trials, innovation, technology, project management, real-world evidence

Speakers

Andy Bevan
MRes CBiol CSci MRSB, Executive Director, Peri- and Post-approval Studies
PDP

Ken Butz
MS, Director, Regulatory Affairs, Medical Devices and Diagnostics
PDP

Tom Healy
Senior Director, Data Architecture, Digital and Decentralized Solutions
PDP

Margaret Moss
MS, Business Optimization Lead, Executive Director, Project Delivery
PDP

Christine Varner
Director, Non-Interventional Studies
PDP

Register Free: http://www.appliedclinicaltrialsonline.com/act/poc

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