The Food and Drug Administration (FDA), Cincinnati Division, is holding a three-day conference on May 5, 6, and 7 entitled "FDA/Xavier University Global Medical Device Conference." The public event is co-sponsored by Xavier University. The notice for the conference is currently in the Federal Register.

Industry experts, FDA officials and global regulators will offer presentations at the conference. The focus is on three areas: quality, regulatory affairs, and clinical research professionals. The topics to be covered include information on:

Global compliance
Global approval process
Global harmonization
Recalls and corrections and removals
Common 483 observations
What happens after an inspection
Medical device reports
Regulatory impact of design and process changes
Integrating internal and external resources for clinical trials
New ways of doing biostatistics
Innovative clinical study design
Challenges in conducting global clinical trials
Comparison of design history file and technical dossier
Integrating risk management in device/combination products
Design controls: Human factors
Labeling and promotion
Corrective and preventive actions
International filing requirements
Promotion of device prior to approval
Combination product filings--tips for successful application
The role of information technology in clinical trials and post-approval process
Bioresearch monitoring early intervention initiatives for electronic recording
Handling images and other non-traditional electronic data

The Federal Register notice contains information on registering for the event, including the address for the conference, contact information and the different registration fees for industry, small business, academics and students.


The Federal Register notice can be accessed at: http://edocket.access.gpo.gov/2010/2010-6865.htm

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