Best Practices for Maintaining an IND and IDE Application with FDA 2012 is a webinar that covers topics such as:
- Amending clinical protocols and informed consent, manufacturing information, providing additional preclinical and clinical information, etc
- IND and IDE annual reports
- What should or should not be submitted in an IND or IDE
- Format, content, editing and submission of various documents to an IND or an IDE
- Adding new clinical protocols to or creating a new IND or IDE for each new protocol
- Adverse event reporting
- Written and verbal request for comments and FDA meetings for further guidance
- Change in sponsor, vendors, investigators, manufacturers, clinical sites, etc
- Differences and similarities between an IND and IDE application logistics and management
- Suspending, reopening, closing and withdrawing an IND or an IDE
- Dos and don`ts of communicating with project management staff at the FDA
Best Practices for Maintaining an IND and IDE Application with FDA 2012 brings together:
- Clinical trial professionals (e.g., CRAs, coordinators)
- Compliance/Regulatory affairs professionals
- Sponsors and investigator-sponsors of clinical trials
- Investigators participating in clinical trials
- Project Managers
- Clinical trial specialists
- People investing in FDA-regulated product development projects
