Design Considerations for Pivotal Clinical Investigations for Medical Devices - Webinar by GlobalCompliancePanel

MessageThis Webinar is over
Date Feb 18, 2014
Time 10:00am
Cost $225.00
This webinar introduces FDA's guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" that was published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data. Following that, it discusses way that are available to a medical device sponsor, for eliminating bias and variance, both in terms of the study design and the requirements for the personnel that will design and run the studies. Finally, it touches on the study protocol and statistical plan and discusses ways to use those to ensure the success of the study. 

Why should you attend:
Each year, insufficient evidence of the safety and effectiveness of a medical device caused from incorrect study design, results in the delay or rejection of either the medical device application or studies conducted towards that application. This is very expensive for the medical device sponsor who has to do additional work or redo existing work. It is also very expensive for the FDA (or other regulatory authorities) who spend the time to review results from incorrectly designed studies. 

To mitigate these issues and standardize the way industry design clinical studies, the FDA published the guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" in late 2013. The FDA's goal in publishing this guidance is to help device manufacturers select the appropriate trial design to: 
  • Better support and improves the quality of safety & effectiveness data submitted to the agency
  • Lead to timelier FDA approval
  • Speed patients' access to new devices
Areas Covered in the Session:
  • The Guidance
  • General Principles
  • Some Principles for the Choice of Clinical Study Design
  • Clinical Outcome Studies
  • Diagnostic Clinical Performance Studies
  • Sustaining the Quality of Clinical Studies
  • Summary
  • Q&A
Who Will Benefit:
  • Clinical Trial Physician / Doctor
  • Manager to Senior Director of Regulatory Affairs
  • Quality Assurance
  • Clinical Research
  • Data Management
  • Data Monitoring
  • Institutional Review Board
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. 

Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel 
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA          
USA Phone:800-447-9407
Fax: 302-288-6884


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