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

Website http://bit.ly/1aJUBjM | Edit Freely

Category Webinar, Health, Medical, Pharma, Clinical

Deadline: February 18, 2014 | Date: February 18, 2014

Venue/Country: USA, U.S.A

Updated: 2014-01-23 13:44:33 (GMT+9)

Call For Papers - CFP

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

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Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

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webinarsglobalcompliancepanel.com

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Event Link - http://bit.ly/1aJUBjM