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

  • 11-12 Apr 2019
  • Boston, MA, United States

Description

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

Past Events

Important

Please, check "Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device

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