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Audio conference highlights
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.
This audio conference covers:
- Requirements for device trials under Title VIII of FDAAA
- Answers to critical questions from the device community
- Responsible parties for trial registration
- Certification form requirements
- Release of the results database
- FDAAA vs. ICMJE registration requirements
About the speaker:
Amy Wise, PhD is Manager of Clinical Research within the Phase IV Development Group at PharmaNet. Amy received her doctorate from Baylor College of Medicine in Houston, TX in 1998 in Molecular and Human Genetics. She has been involved in the conduct of clinical trials for over seven years with a strong focus in medical device project management and clinical monitoring. She has served as the project manager on over 17 medical device studies, including cardiac stents, electrocardiology devices, spinal implants for degenerative disc disease, auto immune diseases, gastroparesis, and peripheral vascular stents.
Who should attend?
- Regulatory Affairs
- Clinical Trial Sponsors
- Medical Researchers
- Legal Counsel
- Clinical Project Managers
*This conference is rated General interest.