Start-Up Strategies for Medical Device Trials

is being presented by Amy Wise, Clinical Research Manager, with PharmaNet Development Group and airs on Wednesday, June 16th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com

The start-up phase of any clinical trial is a hectic time, but there are several areas that require additional consideration and planning for medical device trials. The primary goals of the start-up phase are to distribute and collect documentation to approve each site for the initiation visit so enrollment can begin. However, additonal support and planning is needed by sponsors/CROs for device trials to assist sites with specific tasks such as medicare approval; device shipment, storage, and accountability; planning for maintenance of a blind; and documentation of staff training on the investigational device.

This audio conference discusses how proactive planning and timely responsiveness to site requests can help make the start-up phase for medical device studies more efficient, and can lay the foundation for a positive relationship with the sites that will continue through the life of the study.

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 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

An Introduction to Analyzing Risk in Medical Devices

Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device. This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.

An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com

Executing Phase IV Studies: What Works, What Doesn't

Successful execution of any Phase IV study requires that study processes be streamlined enough to meet the often rapid and commercially-dependent timelines, but rigorous enough to produce data that is rooted in good science and able to stand up to peer review. This balance is often difficult to maintain in the face of changing regulatory and commercial environments.

In this audio conference presentation, the speaker utilizes case studies from recent Phase IV studies to explore what operational strategies worked, what was lacking, and how the CRO/Sponsor relationship was managed.

Executing Phase IV Studies: What Works, What Doesn't was presented by Peggy Schrammel, Vice President Clinical Research, with PharmaNet and aired on 2008-05-29. This conference is available for download at www.fxconferences.com

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

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

Analyzing Risk in Medical Devices

Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device.

This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.

Analyzing Risk in Medical Devices will be presented by Amy Wise, Manager, Clinical Research of PharmaNet. For more information please visit our site www.fxconferences.com.