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

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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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