Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings 2019 is a workshop that covers topics such as:
- Regulatory requirements for IND and IDE application process
- Contents of IND and IDE
- Establishing communications with FDA
- Submissions to IND or IDE to the FDA
- Amendments to IND and IDE applications
- Type of FDA meetings
- Progress reports for IND and IDE
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings 2019 brings together:
- Quality Assurance Management and Staff
- Regulatory Affairs Management and Staff
- Project Managers
- Manufacturing Management and Staff
- Data Managers
- Clinical Research Associates
- Grant Administrators
- Project Team Leaders
- Clinical and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process