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Design Considerations for Pivotal Clinical Investigations for Medical Devices - Webinar by GlobalCompliancePanel
This Webinar is over| Date | Feb 18, 2014 |
| Time | 01:00 PM EDT |
| Cost | $225.00 |
|
Online
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Overview:
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:
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
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
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
- 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
- Clinical Trial Physician / Doctor
- Manager to Senior Director of Regulatory Affairs
- Quality Assurance
- Clinical Research
- Data Management
- Data Monitoring
- Institutional Review Board
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
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
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