Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings 2019 is a conference 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:
- Clinical Research Associates
- Project Managers
- Project Team Leaders with limited direct regulatory experience
- Data Managers
- Regulatory Associates
- Grant Administrators
- Manufacturing, Clinical, and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process
- Quality Assurance specialists