Best Practices for Maintaining an IND and IDE Application with FDA
Wednesday, May 16, 2012 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
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.
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.
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.
Who Will Benefit:
This webinar will provide valuable assistance to the following personnel:
- Compliance/Regulatory affairs professionals
- Clinical trial professionals (e.g., CRAs, coordinators)
- Investigators participating in clinical trials
- Sponsors and investigator-sponsors of clinical trials
- Clinical trial specialists
- Project Managers
- People investing in FDA-regulated product development projects
For Registration :
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.