It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov. Along with mandating the inclusion of medical device trials, additional requirements included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.
One year later, the medical device community still has a lot of questions about requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.
In this audio conference, you will learn the latest information on registration of medical device trials and what you must do for compliance.
Registering Device Trials on ClinicalTrials.gov was presented by Amy Wise, Manager of Clinical Research, with PharmaNet and aired on 2008-11-13. For more details, or to download this event please visit our site at www.fxconferences.com
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Showing posts with label title VIII. Show all posts
Showing posts with label title VIII. Show all posts
Monday, November 30, 2009
Monday, February 9, 2009
Registering Device Trials on ClinicalTrials.gov
It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov. Along with mandating the inclusion of medical device trials, additional requirements included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.
One year later, the medical device community still has a lot of questions about requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.
In this audio conference, you learn the latest information on registration of medical device trials and what you must do for compliance.
Registering Device Trials on ClinicalTrials.gov was presented on 2008-11-13 and is available for download at www.fxconferences.com
One year later, the medical device community still has a lot of questions about requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.
In this audio conference, you learn the latest information on registration of medical device trials and what you must do for compliance.
Registering Device Trials on ClinicalTrials.gov was presented on 2008-11-13 and is available for download at www.fxconferences.com
Labels:
Amy Wise,
clinical trial,
clinicaltrials.gov,
fda,
PharmaNet,
title VIII
Monday, October 6, 2008
Registering Device Trials on ClinicalTrials.gov
It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov and mandated the inclusion of medical device trials. Additional new requirements also included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.
One year later, the medical device community still has a lot of questions about its requirements and responsibilities for compliance with Title VIII, and the FDA is still working on providing the answers and guidance. This audio conference looks at the latest information surrounding registration of medical device trials and what you need to do to be in compliance.
Registering Device Trials on ClinicalTrials.gov is presented by Amy Wise, Manager of Clinical Research, of PharmaNet and airs Thursday, Nov. 13, 2008. For more details or to register, please visit our site www.fxconferences.com
One year later, the medical device community still has a lot of questions about its requirements and responsibilities for compliance with Title VIII, and the FDA is still working on providing the answers and guidance. This audio conference looks at the latest information surrounding registration of medical device trials and what you need to do to be in compliance.
Registering Device Trials on ClinicalTrials.gov is presented by Amy Wise, Manager of Clinical Research, of PharmaNet and airs Thursday, Nov. 13, 2008. For more details or to register, please visit our site www.fxconferences.com
Labels:
Amy Wise,
clinical trial,
clinicaltrials.gov,
fda,
PharmaNet,
title VIII
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