This webinar on IND and IDE Application management will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.
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.
Areas Covered in the Seminar:
- IND and IDE annual reports
- Amending clinical protocols and informed consent, manufacturing information, providing additional preclinical and clinical information, etc.
- Format, content, editing and submission of various documents to an IND or an IDE.
- What should or should not be submitted in an IND or IDE.
- Adverse event reporting.
- Adding new clinical protocols to or creating a new IND or IDE for each new protocol.
- Change in sponsor, vendors, investigators, manufacturers, clinical sites, etc.
- Written and verbal request for comments and FDA meetings for further guidance.
- Suspending, reopening, closing and withdrawing an IND or an IDE.
- Differences and similarities between an IND and IDE application logistics and management.
- Dos and don'ts of communicating with project management staff at the FDA.