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Special
Interest Groups
On December 14, a reinvigorated Clinical Trials Forum met to discuss “Bioresearch
Monitoring in Medical Devices: Practical Considerations when Preparing
for and Responding to FDA Inspections." Susan Rockwell, Manager of
Clinical Trials and Clinical Development at Medical Device Consultants,
Inc. presented an overview of the BIMO program at the CDRH and strategies
companies have used to prepare for FDA inspections.
Kate Giovino, Director of Clinical Operations at Stryker Biotech, discussed
how companies can prepare for inspections in advance of their FDA submissions
and also shared some case studies of her experiences dealing with site
inspections.
The next meeting of the HR Forum will focus on “Emerging Tools in
Performance Management.”
The Small Company Group will meet in early 2007 to discuss “Corporate
Investment in Your Emerging Company: The Do’s and Don’ts.”
For further information about any of the Special Interest Groups, please
contact Laura Allen at allen@massmedic.com.
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December 2006
