Best Practices for Maintaining an IND and IDE Application with FDA 2012

Topics

• 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

Who should Attend

• 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