Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings 2019

Topics

• 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

Who should Attend

• 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