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QUESTIONSBest Practices for Maintaining an IND and IDE Application with FDA (Clinical Compliance)
Venue: Online Event
Location: Palo Alto, California, United States
| Event Date/Time: Jul 26, 2012 | End Date/Time: Jul 26, 2012 |
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Why Should You Attend:
If your company has active IND or IDE applications with the FDA or are planning to file one soon, this seminar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial. You can get valuable tips and training in less than an hour on practical methods for collecting required documents for submission to the FDA, submitting the amendments, follow-up on submissions, and maintaining adequate communications with regulatory project management staff at the FDA. The presenter will share practical tips from his extensive personal experience.
If your company has active IND or IDE applications with the FDA or are planning to file one soon, this seminar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial. You can get valuable tips and training in less than an hour on practical methods for collecting required documents for submission to the FDA, submitting the amendments, follow-up on submissions, and maintaining adequate communications with regulatory project management staff at the FDA. The presenter will share practical tips from his extensive personal experience.
